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Selective Relaxant Binding Agent

Sugammadex 2 mg/kg for Neuromuscular Blockade

Phase 4
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Awards & highlights

Study Summary

This trial will study whether sugammadex is better than neostigmine at reversing moderate neuromuscular blockade in infants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a surgical procedure or medical condition that requires monitoring of your neuromuscular transmission.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A. Apparent Volume of Distribution (Vz) for Sugammadex
Part A. Apparent Volume of Distribution at Steady State (Vss) for Sugammadex
Part A. Area Under the Plasma Concentration Time Curve (AUC) for Sugammadex
+5 more
Secondary outcome measures
Part B. Time to Extubation

Side effects data

From 2019 Phase 4 trial • 344 Patients • NCT03346057
46%
Procedural pain
28%
Incision site pain
19%
Nausea
9%
Constipation
7%
Sinus tachycardia
7%
Hypotension
7%
Procedural nausea
6%
Hypokalaemia
6%
Insomnia
6%
Hypoxia
6%
Postoperative hypertension
4%
Tachycardia
4%
Vomiting
3%
Hypoaesthesia
3%
Asthenia
3%
Headache
1%
Bradycardia
1%
Heparin-induced thrombocytopenia
1%
Acute myocardial infarction
1%
Cardiac arrest
1%
Bronchitis
1%
Urinary bladder haemorrhage
1%
Rash
1%
Gallbladder abscess
1%
C-reactive protein increased
1%
Dyspnoea
1%
Haemoglobin decreased
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sugammadex 16 mg/kg
Sugammadex 2 mg/kg
Sugammadex 4 mg/kg
Neostigmine + Glycopyrrolate

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Part B. Sugammadex 4 mg/kgExperimental Treatment1 Intervention
Single IV bolus of sugammadex at 4 mg/kg.
Group II: Part B. Sugammadex 2 mg/kgExperimental Treatment1 Intervention
Single IV bolus of sugammadex at 2 mg/kg.
Group III: Part A. Sugammadex 4 mg/kgExperimental Treatment1 Intervention
Single IV bolus of sugammadex at 4 mg/kg.
Group IV: Part A. Sugammadex 2 mg/kgExperimental Treatment1 Intervention
Single intravenous (IV) bolus of sugammadex at 2 mg/kg
Group V: Part B. NeostigmineActive Control2 Interventions
Single IV 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex 4 mg/kg
2018
Completed Phase 4
~1350
Sugammadex 2 mg/kg
2018
Completed Phase 4
~910

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,146 Total Patients Enrolled
14 Trials studying Neuromuscular Blockade
3,190 Patients Enrolled for Neuromuscular Blockade
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,837 Total Patients Enrolled
35 Trials studying Neuromuscular Blockade
42,748 Patients Enrolled for Neuromuscular Blockade
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,727 Total Patients Enrolled
5 Trials studying Neuromuscular Blockade
644 Patients Enrolled for Neuromuscular Blockade

Media Library

Sugammadex (Selective Relaxant Binding Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03909165 — Phase 4
Neuromuscular Blockade Research Study Groups: Part A. Sugammadex 2 mg/kg, Part A. Sugammadex 4 mg/kg, Part B. Sugammadex 2 mg/kg, Part B. Sugammadex 4 mg/kg, Part B. Neostigmine
Neuromuscular Blockade Clinical Trial 2023: Sugammadex Highlights & Side Effects. Trial Name: NCT03909165 — Phase 4
Sugammadex (Selective Relaxant Binding Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03909165 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for enrolment in this trial?

"This medical trial is enrolling 126 infants between the day of birth and two years old who require neuromuscular blockade for a non-emergency surgical procedure or intubation. Prospective participants must meet all these requirements: they have to be either male or female, no older than 2 years, and their situation has to permit the use of monitoring techniques during neuromuscular transmission."

Answered by AI

Does the criteria for this study allow individuals over 25 years of age to participate?

"This clinical trial requires that participants are between infant age and 2 years old. Separately, there are 16 studies for those below 18 and 43 for the elderly demographic (over 65)."

Answered by AI

What potential adverse effects should be anticipated when administering Sugammadex 2 mg/kg to patients?

"Sugammadex 2 mg/kg is approved as a Phase 4 medication and thus has been assigned the maximum safety rating of 3."

Answered by AI

Is this experiment still accepting participants?

"According to the listing on clinicaltrials.gov, this medical trial is presently searching for patients to take part in its research. It was inaugurated back on July 23rd 2019 and underwent a subsequent update two years later, on September 17th 2022."

Answered by AI

What is the typical application of Sugammadex 2 mg/kg?

"Sugammadex 2 mg/kg is most frequently prescribed for reflex and trigeminocardiac ailments. It has also displayed efficacy in treating bodily secretions, denture retention, and ureteric colic related symptoms."

Answered by AI

Have any past experiments tested the efficacy of Sugammadex 2 mg/kg?

"Sugammadex 2 mg/kg has been a subject of research since 2009, when South Texas Veterans Health Care System first began trials. In total, 342 studies have already concluded and 43 are ongoing - many in Houston, TX."

Answered by AI

To what extent is this experiment being participated in by individuals?

"Affirmative. Clinicaltrials.gov indicates that this research is recruiting patients, having been initially posted on July 23rd 2019 and most recently edited September 17th 2022. 126 participants are sought from 3 different sites for the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
2019. "Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03909165.
~24 spots leftby Apr 2025
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