A Phase 4 interventional study of Sugammadex 2 mg/kg and Sugammadex 4 mg/kg in Reversal of Neuromuscular Blockade, sponsored by Merck Sharp & Dohme LLC. Completed at 30 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Treatment
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 344 is above the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
Drug: Sugammadex 2 mg/kg · Drug: Rocuronium · Drug: Vecuronium
Sugammadex 4 mg/kg administered as a single IV dose
Drug: Sugammadex 4 mg/kg · Drug: Rocuronium · Drug: Vecuronium
Sugammadex 16 mg/kg administered as a single IV dose
Drug: Sugammadex 16 mg/kg · Drug: Rocuronium
Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose
Drug: Neostigmine + Glycopyrrolate · Drug: Rocuronium · Drug: Vecuronium
Drug page: Sugammadex
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex 2 mg/kg for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
Also known as: MK-8616, Bridion
Drug page: Sugammadex
Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 4 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
Also known as: MK-8616, Bridion
Drug page: Sugammadex
Following administration of NMBA (Rocuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 16 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
Also known as: MK-8616, Bridion
Drug pages: Neostigmine · Glycopyrrolate
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 μg/kg; 5 mg maximum) and Glycopyrrolate (10 μg/kg; 1 mg maximum) for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
To achieve NMB, participants received steroidal NMBA Rocuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
To achieve NMB, participants received steroidal NMBA Vecuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate \<60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as determined by investigator judgment.
Time frame: Up to approximately 35 minutes post-administration
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
The percentage of participants experiencing treatment-emergent sinus tachycardia events was identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not have been considered an AE, as determined by investigator judgment.
Time frame: Up to approximately 35 minutes post-administration
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.
Time frame: Up to approximately 35 minutes post-administration
Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention
As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
Time frame: Up to 7 days
Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention
As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose.
Time frame: Up to 7 days
Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention
As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. A participant could have experienced more than one type of ECI.
Time frame: Up to 7 days
| Milestone | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Started | 111 | 112 | 68 | 53 |
| Treated | 105 | 107 | 68 | 51 |
| Completed | 104 | 104 | 67 | 51 |
| Not completed | 7 | 8 | 1 | 2 |
| Withdrew: Death | 1 | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 1 | 0 |
| Withdrew: Ineligible for study - not treated | 0 | 1 | 0 | 0 |
| Withdrew: Renal insufficiency - not treated | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 3 | 2 | 0 | 2 |
| Withdrew: Randomization mistake - not treated | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate \<60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as determined by investigator judgment.
| Percentage of participants | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events | 1.0 | 1.9 | 7.4 | 7.8 |
The percentage of participants experiencing treatment-emergent sinus tachycardia events was identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not have been considered an AE, as determined by investigator judgment.
| Percentage of participants | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events | 6.7 | 9.3 | 8.8 | 21.6 |
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.
| Percentage of participants | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events | 1.0 | 0.0 | 1.5 | 2.0 |
As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
| Percentage of participants | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention | 94.3 | 88.8 | 92.6 | 88.2 |
As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose.
| Percentage of Participants | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention | 11.4 | 7.5 | 10.3 | 5.9 |
As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. A participant could have experienced more than one type of ECI.
| Percentage of Participants | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| With one or more ECIs | 1.9 | 5.6 | 7.4 | 3.9 |
| Adjudicated Hypersensitivity | 0.0 | 0.0 | 0.0 | 0.0 |
| Adjudicated Anaphylaxis | 0.0 | 0.0 | 0.0 | 0.0 |
| Clinically Relevant Bradycardia | 0.0 | 2.8 | 0.0 | 2.0 |
| Clinically Relevant Tachycardia | 1.9 | 1.9 | 5.9 | 0.0 |
| Other Clinically Relevant Cardiac Arrhythmia | 0.0 | 0.9 | 1.5 | 2.0 |
| Drug Induced Liver Injury | 0.0 | 0.0 | 0.0 | 0.0 |
Collected over Up to approximately 21 days post treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugammadex 2 mg/kg | 1/111 (0.9%) | 16/105 (15.2%) | 89/105 (84.8%) |
| Sugammadex 4 mg/kg | 2/112 (1.8%) | 12/107 (11.2%) | 89/107 (83.2%) |
| Sugammadex 16 mg/kg | 0/68 (0%) | 9/68 (13.2%) | 60/68 (88.2%) |
| Neostigmine + Glycopyrrolate | 0/53 (0%) | 4/51 (7.8%) | 41/51 (80.4%) |
| Event | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Small intestinal obstructionGastrointestinal disorders | 0/105 | 0/107 | 0/68 | 1/51 |
| Catheter site haemorrhageGeneral disorders | 0/105 | 0/107 | 0/68 | 1/51 |
| Abdominal wound dehiscenceInjury, poisoning and procedural complications | 2/105 | 0/107 | 0/68 | 1/51 |
| Postoperative ileusInjury, poisoning and procedural complications | 0/105 | 0/107 | 0/68 | 1/51 |
| Impaired healingGeneral disorders | 2/105 | 0/107 | 0/68 | 0/51 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 2/105 | 0/107 | 0/68 | 0/51 |
| HaematuriaRenal and urinary disorders | 0/105 | 2/107 | 0/68 | 0/51 |
| Heparin-induced thrombocytopeniaBlood and lymphatic system disorders | 0/105 | 0/107 | 1/68 | 0/51 |
| Acute myocardial infarctionCardiac disorders | 0/105 | 0/107 | 1/68 | 0/51 |
| Cardiac arrestCardiac disorders | 1/105 | 0/107 | 1/68 | 0/51 |
| Event | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 58/105 | 56/107 | 31/68 | 27/51 |
| Incision site painInjury, poisoning and procedural complications | 25/105 | 31/107 | 19/68 | 9/51 |
| NauseaGastrointestinal disorders | 17/105 | 19/107 | 13/68 | 7/51 |
| ConstipationGastrointestinal disorders | 7/105 | 7/107 | 6/68 | 2/51 |
| TachycardiaCardiac disorders | 5/105 | 8/107 | 3/68 | 4/51 |
| Procedural nauseaInjury, poisoning and procedural complications | 4/105 | 2/107 | 5/68 | 4/51 |
| HeadacheNervous system disorders | 3/105 | 5/107 | 2/68 | 4/51 |
| HypotensionVascular disorders | 6/105 | 8/107 | 5/68 | 4/51 |
| InsomniaPsychiatric disorders | 3/105 | 8/107 | 4/68 | 2/51 |
| Sinus tachycardiaCardiac disorders | 2/105 | 3/107 | 5/68 | 1/51 |
All randomized participants
| Age, Continuous(Years) | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate | Total |
|---|---|---|---|---|---|
| Mean | 69.5 ± 10.7 | 67.8 ± 12.1 | 69.4 ± 10.0 | 66.6 ± 10.9 | 68.5 ± 11.1 |
| Sex: Female, Male(Participants) | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate | Total |
|---|---|---|---|---|---|
| Female | 50 | 41 | 29 | 15 | 135 |
| Male | 61 | 71 | 39 | 38 | 209 |
| Ethnicity (NIH/OMB)(Participants) | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 6 | 0 | 2 | 10 |
| Not Hispanic or Latino | 109 | 105 | 67 | 51 | 332 |
| Unknown or Not Reported | 0 | 1 | 1 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 0 | 0 | 2 |
| Black or African American | 3 | 9 | 2 | 3 | 17 |
| White | 106 | 103 | 66 | 50 | 325 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Participant Stratifications(Participants) | Sugammadex 2 mg/kg | Sugammadex 4 mg/kg | Sugammadex 16 mg/kg | Neostigmine + Glycopyrrolate | Total |
|---|---|---|---|---|---|
| Rocuronium, ASA Class 3 | 50 | 49 | 51 | 25 | 175 |
| Rocuronium, ASA Class 4 | 15 | 18 | 17 | 8 | 58 |
| Vecuronium, ASA Class 3 | 29 | 31 | 0 | 14 | 74 |
| Vecuronium, ASA Class 4 | 11 | 11 | 0 | 5 | 27 |
| Missing | 6 | 3 | 0 | 1 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Dec 2017 to primary completion in Sep 2019, 20 months.
Results were first posted in Oct 2020, 1 year 1 month after primary completion.
Of 24 phase 4 interventional studies under Arrhythmias, Cardiac, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sugammadex · Vecuronium