A Phase 3 interventional study of sugammadex and neostigmine in Anesthesia, General, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Drug: sugammadex · Drug: rocuronium
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Drug: neostigmine · Drug: rocuronium · Drug: glycopyrrolate
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Drug: sugammadex · Drug: vecuronium
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Drug: neostigmine · Drug: vecuronium · Drug: glycopyrrolate
Administered as an intravenous (IV) infusion
Also known as: Org 25969, MK-8616, BRIDION®
Administered as an IV infusion
Also known as: PROSTIGMIN®
Administered as an IV infusion
Also known as: NORCURON®
Administered as an IV infusion
Also known as: ZEMURON®
Administered as an IV infusion
Also known as: ROBINUL®
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time frame: Up to approximately 3 hours after administration of study drug
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time frame: Up to approximately 6 hours after administration of study drug
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time frame: Up to approximately 2 hours after administration of study drug
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time frame: Up to approximately 4 hours after administration of study drug
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time frame: Up to approximately 3 hours after administration of study drug
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time frame: Up to approximately 5 hours after administration of study drug
Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness)
The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
Time frame: Up to 24 hours
Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
Time frame: Up to 24 hours
Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
Time frame: Up to 24 hours
Number of Participants Able to Perform a 5-second Head Lift
The number of participants who were able to lift their head for 5 seconds was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. Participants who were not cooperative with the examination were not included in the assessment.
Time frame: Up to 24 hours
Number of Participants Experiencing General Muscle Weakness
The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. Participants who were not cooperative with the examination were not included in the assessment.
Time frame: Up to 24 hours
The trial was conducted in 8 trial sites in the United States. A total of 182 participants were randomized with 157 participants treated.
| Milestone | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Started | 48 | 41 | 51 | 42 |
| Treated | 37 | 38 | 46 | 36 |
| Completed | 37 | 37 | 46 | 35 |
| Not completed | 11 | 4 | 5 | 7 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Withdrew: Participants did not receive treatment | 11 | 3 | 5 | 6 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
| Minutes | Rocuronium+Sugammadex | Rocuronium+Neostigmine |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium | 3.28 ± 2.40 | 55.50 ± 27.10 |
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
| Minutes | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium | 8.73 ± 14.60 | 77.80 ± 56.98 |
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
| Minutes | Rocuronium+Sugammadex | Rocuronium+Neostigmine |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium | 2.27 ± 1.25 | 37.68 ± 21.88 |
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
| Minutes | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium | 4.10 ± 8.78 | 56.17 ± 36.65 |
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
| Minutes | Rocuronium+Sugammadex | Rocuronium+Neostigmine |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium | 2.65 ± 1.58 | 45.82 ± 24.95 |
Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
| Minutes | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|
| Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium | 5.55 ± 9.87 | 67.42 ± 44.85 |
The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
| Participants | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Prior to transfer to recovery room | 26 | 20 | 27 | 20 |
| Prior to discharge from recovery room | 34 | 32 | 39 | 33 |
The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
| Participants | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Prior to transfer to recovery room | 9 | 11 | 12 | 8 |
| Prior to discharge from recovery room | 0 | 1 | 2 | 1 |
The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
| Participants | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Prior to transfer to recovery room | 2 | 3 | 7 | 7 |
| Prior to discharge from recovery room | 0 | 0 | 0 | 0 |
The number of participants who were able to lift their head for 5 seconds was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. Participants who were not cooperative with the examination were not included in the assessment.
| Participants | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Prior to transfer to recovery room | 33 | 28 | 36 | 24 |
| Prior to discharge from recovery room | 34 | 33 | 41 | 33 |
The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. Participants who were not cooperative with the examination were not included in the assessment.
| Participants | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Prior to transfer to recovery room | 3 | 5 | 4 | 2 |
| Prior to discharge from recovery room | 2 | 3 | 1 | 3 |
Collected over Up to 7 days after administration of study drug. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rocuronium+Sugammadex | 0/37 (0%) | 2/37 (5.4%) | 36/37 (97.3%) |
| Rocuronium+Neostigmine | 0/38 (0%) | 3/38 (7.9%) | 37/38 (97.4%) |
| Vecuronium+Sugammadex | 0/46 (0%) | 2/46 (4.3%) | 46/46 (100%) |
| Vecuronium+Neostigmine | 0/36 (0%) | 0/36 (0%) | 33/36 (91.7%) |
| Event | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Postoperative infectionInfections and infestations | 1/37 | 0/38 | 0/46 | 0/36 |
| Postoperative ileusInjury, poisoning and procedural complications | 1/37 | 1/38 | 0/46 | 0/36 |
| Gastric perforationGastrointestinal disorders | 0/37 | 1/38 | 0/46 | 0/36 |
| NauseaGastrointestinal disorders | 0/37 | 1/38 | 0/46 | 0/36 |
| PainGeneral disorders | 0/37 | 1/38 | 0/46 | 0/36 |
| Procedural complicationInjury, poisoning and procedural complications | 0/37 | 1/38 | 0/46 | 0/36 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/37 | 1/38 | 0/46 | 0/36 |
| Splenic abscessInfections and infestations | 0/37 | 0/38 | 1/46 | 0/36 |
| AtelectasisRespiratory, thoracic and mediastinal disorders | 0/37 | 0/38 | 1/46 | 0/36 |
| Event | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine |
|---|---|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 26/37 | 29/38 | 33/46 | 24/36 |
| NauseaGastrointestinal disorders | 14/37 | 19/38 | 24/46 | 12/36 |
| HeadacheNervous system disorders | 3/37 | 4/38 | 12/46 | 2/36 |
| Incision site complicationInjury, poisoning and procedural complications | 9/37 | 8/38 | 10/46 | 8/36 |
| VomitingGastrointestinal disorders | 5/37 | 7/38 | 9/46 | 4/36 |
| Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders | 3/37 | 4/38 | 8/46 | 7/36 |
| Post procedural nauseaInjury, poisoning and procedural complications | 7/37 | 5/38 | 5/46 | 2/36 |
| FlatulenceGastrointestinal disorders | 6/37 | 2/38 | 1/46 | 0/36 |
| Procedural complicationInjury, poisoning and procedural complications | 2/37 | 6/38 | 2/46 | 2/36 |
| InsomniaPsychiatric disorders | 5/37 | 4/38 | 4/46 | 2/36 |
The analysis population was all randomized participants.
| Age, Continuous(Years) | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine | Total |
|---|---|---|---|---|---|
| Mean | 53.6 ± 14.0 | 54.0 ± 10.8 | 49.9 ± 13.6 | 55.2 ± 13.3 | 53.0 ± 13.1 |
| Sex: Female, Male(Participants) | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine | Total |
|---|---|---|---|---|---|
| Female | 26 | 20 | 33 | 21 | 100 |
| Male | 22 | 20 | 19 | 21 | 82 |
| Race (NIH/OMB)(Participants) | Rocuronium+Sugammadex | Rocuronium+Neostigmine | Vecuronium+Sugammadex | Vecuronium+Neostigmine | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 3 | 1 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 7 | 2 | 13 |
| White | 43 | 36 | 43 | 37 | 159 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 1 | 0 | 3 |
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