A Phase 4 interventional study of Sugammadex 2 mg/kg and Sugammadex 4 mg/kg in Neuromuscular Blockade, sponsored by Merck Sharp & Dohme LLC. Completed at 30 sites in 8 countries. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Treatment
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This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium or vecuronium in pediatric participants. The primary efficacy hypothesis of this investigation is that sugammadex is superior to neostigmine in reversing moderate NMB in pediatric participants as measured by time to recovery to a train-of-four (TOF) ratio of ≥0.9.
This trial will be conducted in two parts: Part A and Part B. In Part A, pharmacokinetic (PK) sampling will be conducted to identify the pediatric dose providing sugammadex exposure similar to adults. For Part B participants, the efficacy of sugammadex (i.e. time to recovery of the TOF ratio) will be assessed. Further, safety analyses will be conducted in both Parts A and B. Following completion of Part A, an interim analysis (IA) of the PK and safety data will be performed. Once the appropriate doses are confirmed and safety data is assessed for the 2 doses of sugammadex, then Part B will commence.
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
Single intravenous (i.v.) bolus of sugammadex at 2 mg/kg.
Drug: Sugammadex 2 mg/kg
Single i.v. bolus of sugammadex at 4 mg/kg.
Drug: Sugammadex 4 mg/kg
Single i.v. bolus of sugammadex at 2 mg/kg.
Drug: Sugammadex 2 mg/kg
Single i.v. bolus of sugammadex at 4 mg/kg.
Drug: Sugammadex 4 mg/kg
Single i.v. bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg).
Drug: Neostigmine + Glycopyrrolate · Drug: Neostigmine + Atropine
Drug page: Sugammadex
For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
Also known as: MK-8616, BRIDION®
Drug page: Sugammadex
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
Also known as: MK-8616, BRIDION®
Drug pages: Neostigmine · Glycopyrrolate
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
Drug pages: Neostigmine · Atropine
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A]
The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm.
Time frame: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Plasma Clearance (CL) of Sugammadex [Part A]
The CL of sugammadex, defined as the rate of elimination relative to plasma concentration, was determined in each Part A arm.
Time frame: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Apparent Volume of Distribution (Vz) of Sugammadex [Part A]
The Vz of sugammadex, defined as the amount of drug administered relative to plasma concentrations, was determined in each Part A arm.
Time frame: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Maximum Plasma Concentration (Cmax) of Sugammadex [Part A]
The Cmax of sugammadex, defined as the maximum plasma concentration, was determined in each Part A arm.
Time frame: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Plasma Half-Life (t½) of Sugammadex [Part A]
The t½ of sugammadex, defined as the time required for the plasma concentration to decrease to 50% of maximum, was determined in each Part A arm.
Time frame: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B]
The percentage of participants with ≥1 AE(s) for up to 7 days after treatment was determined for each treatment group, pooled according to treatment received. An AE is defined as any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated.
Time frame: Up to 7 days
Time to Recovery of Participant Train-of-Four (TOF) Ratio to ≥0.9 [Part B]
The time to recovery of TOF ratio to ≥0.9 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB. Per protocol, the efficacy analysis is based on comparison of the Part B: Sugammadex 2 mg arm versus the Part B: Neostigmine + (Glycopyrrolate or Atropine) arm.
Time frame: Up to 30 minutes post-dose
Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B]
The time to recovery of TOF ratio to ≥0.7 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.
Time frame: Up to 30 minutes post-dose
Time to Recovery of Participant TOF Ratio to ≥0.8 [Part B]
The time to recovery of TOF ratio to ≥0.8 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.
Time frame: Up to 30 minutes post-dose
Male and female participants 2 to \<17 years of age who are categorized as American Society of Anesthesiologists (ASA) Physical Class 1, 2, or 3 and had a planned medical and/or surgical procedure requiring moderate or deep neuromuscular blockade (NMB) with rocuronium (ROC) or vecuronium (VEC) that would allow for neuromuscular monitoring were recruited.
| Milestone | Part A: Sugammadex 2 mg/kg | Part A: Sugammadex 4 mg | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) |
|---|---|---|---|---|---|
| Started | 19 | 23 | 35 | 176 | 35 |
| Treated | 18 | 22 | 33 | 169 | 34 |
| Completed | 18 | 21 | 32 | 168 | 33 |
| Not completed | 1 | 2 | 3 | 8 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 1 | 1 |
| Withdrew: Physician decision | 1 | 0 | 0 | 2 | 1 |
| Withdrew: Randomized by mistake, no treatment given | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by parent/guardian | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Other | 0 | 1 | 1 | 3 | 0 |
The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm.
| hr*μg/mL | Part A: Sugammadex 2 mg (2 to <6 Years) | Part A: Sugammadex 2 mg (6 to <12 Years) | Part A: Sugammadex 2 mg (12 to <17 Years) | Part A: Sugammadex 4 mg (2 to <6 Years) | Part A: Sugammadex 4 mg (6 to <12 Years) | Part A: Sugammadex 4 mg (12 to <17 Years) |
|---|---|---|---|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A] | 14.1 ± 19.4 | 18.8 ± 27.4 | 27.6 ± 58.0 | 26.9 ± 18.5 | 38.2 ± 73.0 | 49.2 ± 20.1 |
The CL of sugammadex, defined as the rate of elimination relative to plasma concentration, was determined in each Part A arm.
| L/hr | Part A: Sugammadex 2 mg (2 to <6 Years) | Part A: Sugammadex 2 mg (6 to <12 Years) | Part A: Sugammadex 2 mg (12 to <17 Years) | Part A: Sugammadex 4 mg (2 to <6 Years) | Part A: Sugammadex 4 mg (6 to <12 Years) | Part A: Sugammadex 4 mg (12 to <17 Years) |
|---|---|---|---|---|---|---|
| Plasma Clearance (CL) of Sugammadex [Part A] | 2.30 ± 21.4 | 3.58 ± 26.2 | 4.68 ± 52.5 | 2.26 ± 29.4 | 3.43 ± 105 | 5.69 ± 24.1 |
The Vz of sugammadex, defined as the amount of drug administered relative to plasma concentrations, was determined in each Part A arm.
| Liters | Part A: Sugammadex 2 mg (2 to <6 Years) | Part A: Sugammadex 2 mg (6 to <12 Years) | Part A: Sugammadex 2 mg (12 to <17 Years) | Part A: Sugammadex 4 mg (2 to <6 Years) | Part A: Sugammadex 4 mg (6 to <12 Years) | Part A: Sugammadex 4 mg (12 to <17 Years) |
|---|---|---|---|---|---|---|
| Apparent Volume of Distribution (Vz) of Sugammadex [Part A] | 3.58 ± 21.3 | 6.65 ± 33.5 | 10.8 ± 34.8 | 4.00 ± 37.7 | 8.22 ± 82.9 | 12.3 ± 35.9 |
The Cmax of sugammadex, defined as the maximum plasma concentration, was determined in each Part A arm.
| µg/mL | Part A: Sugammadex 2 mg (2 to <6 Years) | Part A: Sugammadex 2 mg (6 to <12 Years) | Part A: Sugammadex 2 mg (12 to <17 Years) | Part A: Sugammadex 4 mg (2 to <6 Years) | Part A: Sugammadex 4 mg (6 to <12 Years) | Part A: Sugammadex 4 mg (12 to <17 Years) |
|---|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of Sugammadex [Part A] | 17.5 ± 33.1 | 32.2 ± 15.6 | 41.3 ± 85.8 | 47.1 ± 22.1 | 51.6 ± 69.2 | 61.9 ± 13.5 |
The t½ of sugammadex, defined as the time required for the plasma concentration to decrease to 50% of maximum, was determined in each Part A arm.
| Hours | Part A: Sugammadex 2 mg (2 to <6 Years) | Part A: Sugammadex 2 mg (6 to <12 Years) | Part A: Sugammadex 2 mg (12 to <17 Years) | Part A: Sugammadex 4 mg (2 to <6 Years) | Part A: Sugammadex 4 mg (6 to <12 Years) | Part A: Sugammadex 4 mg (12 to <17 Years) |
|---|---|---|---|---|---|---|
| Plasma Half-Life (t½) of Sugammadex [Part A] | 1.15 (0.964 to 1.64) | 1.19 (1.01 to 1.71) | 1.49 (1.17 to 1.91) | 1.12 (0.922 to 1.78) | 1.56 (1.21 to 3.06) | 1.51 (1.20 to 1.91) |
The percentage of participants with ≥1 AE(s) for up to 7 days after treatment was determined for each treatment group, pooled according to treatment received. An AE is defined as any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated.
| Percentage of Participants | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Parts A and B: Sugammadex 2 mg | Parts A and B: Sugammadex 4 mg |
|---|---|---|---|
| Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B] | 97.1 | 78.4 | 74.9 |
The time to recovery of TOF ratio to ≥0.9 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB. Per protocol, the efficacy analysis is based on comparison of the Part B: Sugammadex 2 mg arm versus the Part B: Neostigmine + (Glycopyrrolate or Atropine) arm.
| Minutes | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) |
|---|---|---|---|
| Time to Recovery of Participant Train-of-Four (TOF) Ratio to ≥0.9 [Part B] | 1.6 ± 1.3 | 1.9 ± 1.7 | 7.5 ± 5.6 |
The time to recovery of TOF ratio to ≥0.7 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.
| Minutes | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) |
|---|---|---|---|
| Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B] | 1.1 ± 0.9 | 1.3 ± 1.1 | 3.7 ± 2.9 |
The time to recovery of TOF ratio to ≥0.8 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.
| Minutes | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) |
|---|---|---|---|
| Time to Recovery of Participant TOF Ratio to ≥0.8 [Part B] | 1.3 ± 1.1 | 1.5 ± 1.3 | 5.0 ± 3.8 |
Collected over Up to 14 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Sugammadex 2 mg (2 to <6 Years) | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| Part A: Sugammadex 2 mg (6 to <12 Years) | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Part A: Sugammadex 2 mg (12 to <17 Years) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Part A: Sugammadex 4 mg (2 to <6 Years) | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Part A: Sugammadex 4 mg (6 to <12 Years) | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Part A: Sugammadex 4 mg (12 to <17 Years) | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Part B: Sugammadex 2 mg | 0/33 (0%) | 3/33 (9.1%) | 26/33 (78.8%) |
| Part B: Sugammadex 4 mg | 0/169 (0%) | 3/169 (1.8%) | 117/169 (69.2%) |
| Part B: Neostigmine + (Glycopyrrolate or Atropine) | 0/34 (0%) | 2/34 (5.9%) | 29/34 (85.3%) |
| Event | Part A: Sugammadex 2 mg (2 to <6 Years) | Part A: Sugammadex 2 mg (6 to <12 Years) | Part A: Sugammadex 2 mg (12 to <17 Years) | Part A: Sugammadex 4 mg (2 to <6 Years) | Part A: Sugammadex 4 mg (6 to <12 Years) | Part A: Sugammadex 4 mg (12 to <17 Years) | Part B: Sugammadex 2 mg | Part B: Sugammadex 4 mg | Part B: Neostigmine + (Glycopyrrolate or Atropine) |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infectionInfections and infestations | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 1/33 | 0/169 | 0/34 |
| Post procedural bile leakInjury, poisoning and procedural complications | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 1/33 | 0/169 | 0/34 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 1/33 | 0/169 | 0/34 |
| DehydrationMetabolism and nutrition disorders | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 0/169 | 1/34 |
| LaryngospasmRespiratory, thoracic and mediastinal disorders | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 0/169 | 1/34 |
| Abdominal painGastrointestinal disorders | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 1/169 | 0/34 |
| PyrexiaGeneral disorders | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 1/169 | 0/34 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 1/169 | 0/34 |
| Event | Part A: Sugammadex 2 mg (2 to <6 Years) | Part A: Sugammadex 2 mg (6 to <12 Years) | Part A: Sugammadex 2 mg (12 to <17 Years) | Part A: Sugammadex 4 mg (2 to <6 Years) | Part A: Sugammadex 4 mg (6 to <12 Years) | Part A: Sugammadex 4 mg (12 to <17 Years) | Part B: Sugammadex 2 mg | Part B: Sugammadex 4 mg | Part B: Neostigmine + (Glycopyrrolate or Atropine) |
|---|---|---|---|---|---|---|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 4/9 | 3/5 | 1/4 | 7/10 | 3/6 | 3/6 | 22/33 | 98/169 | 24/34 |
| Mouth swellingGastrointestinal disorders | 0/9 | 2/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 0/169 | 0/34 |
| Incision site painInjury, poisoning and procedural complications | 0/9 | 0/5 | 1/4 | 0/10 | 1/6 | 0/6 | 2/33 | 5/169 | 1/34 |
| Procedural nauseaInjury, poisoning and procedural complications | 0/9 | 0/5 | 1/4 | 0/10 | 0/6 | 0/6 | 3/33 | 9/169 | 0/34 |
| Procedural vomitingInjury, poisoning and procedural complications | 0/9 | 0/5 | 1/4 | 1/10 | 0/6 | 0/6 | 2/33 | 4/169 | 1/34 |
| HeadacheNervous system disorders | 2/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 1/33 | 2/169 | 1/34 |
| HaematuriaRenal and urinary disorders | 2/9 | 0/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 2/169 | 0/34 |
| BradycardiaCardiac disorders | 1/9 | 1/5 | 0/4 | 1/10 | 1/6 | 1/6 | 1/33 | 9/169 | 3/34 |
| DiarrhoeaGastrointestinal disorders | 0/9 | 1/5 | 0/4 | 0/10 | 0/6 | 0/6 | 0/33 | 1/169 | 0/34 |
| VomitingGastrointestinal disorders | 0/9 | 1/5 | 0/4 | 0/10 | 0/6 | 0/6 | 3/33 | 20/169 | 2/34 |
| Age, Continuous(years) | Part A: Sugammadex 2 mg/kg | Part A: Sugammadex 4 mg | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Total |
|---|---|---|---|---|---|---|
| Mean | 7.1 ± 4.7 | 7.2 ± 5.0 | 7.9 ± 4.4 | 7.9 ± 4.4 | 8.7 ± 4.4 | 7.9 ± 4.4 |
| Age, Customized(Participants) | Part A: Sugammadex 2 mg/kg | Part A: Sugammadex 4 mg | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Total |
|---|---|---|---|---|---|---|
| Children (2-11 years) | 15 | 17 | 25 | 132 | 25 | 214 |
| Adolescents (12-17 years) | 4 | 6 | 10 | 44 | 10 | 74 |
| Sex: Female, Male(Participants) | Part A: Sugammadex 2 mg/kg | Part A: Sugammadex 4 mg | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Total |
|---|---|---|---|---|---|---|
| Female | 11 | 12 | 20 | 95 | 18 | 156 |
| Male | 8 | 11 | 15 | 81 | 17 | 132 |
| Race (NIH/OMB)(Participants) | Part A: Sugammadex 2 mg/kg | Part A: Sugammadex 4 mg | Part B: Sugammadex 2 mg/kg | Part B: Sugammadex 4 mg/kg | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 0 | 1 |
| Asian | 0 | 2 | 3 | 5 | 2 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 1 | 2 | 0 | 6 |
| White | 16 | 17 | 30 | 161 | 33 | 257 |
| More than one race | 2 | 1 | 0 | 4 | 0 | 7 |
| Unknown or Not Reported | 0 | 0 | 1 | 4 | 0 | 5 |
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 Feb 2018 to primary completion in Jan 2020, 23 months.
Results were first posted in Feb 2021, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sugammadex