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NCT03346070 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)
A Phase 4 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 4
- Development phase
- 207
- Enrollment target
NCT03346070: Completed Phase 4 study, sponsored by Merck Sharp & Dohme.
NCT03346070 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 207 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03346070, a Phase 4 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 207 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.
Primary Outcome
The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recov
Interventions
- DRUG Neostigmine + Glycopyrrolate
- DRUG Sugammadex 2 mg/kg ABW
- DRUG Sugammadex 2 mg/kg IBW
- DRUG Sugammadex 4 mg/kg ABW
- DRUG Sugammadex 4 mg/kg IBW
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2018-01-01 |
| Est. Completion | 2019-01-29 |
| Phase | Phase 4 |
What the finished NCT03346070 record still lists
NCT03346070 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Neostigmine + Glycopyrrolate is the first listed.
NCT03346070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03346070 about?
NCT03346070 is a clinical study titled "Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)". The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly...
What is the current status of trial NCT03346070?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 207 participants. The study started on 2018-01-01. Estimated completion is 2019-01-29.
What interventions are being tested in trial NCT03346070?
The interventions under investigation include: Neostigmine + Glycopyrrolate (DRUG), Sugammadex 2 mg/kg ABW (DRUG), Sugammadex 2 mg/kg IBW (DRUG), Sugammadex 4 mg/kg ABW (DRUG), Sugammadex 4 mg/kg IBW (DRUG).
Who is sponsoring clinical trial NCT03346070?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03346070's enrollment target sits among peer trials
207 401st of 2000 higher than 1,600 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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