Phase 3
Completed N=115
Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)
Anesthesia, General
Source: ClinicalTrials.gov NCT00474253 ↗
Enrolled (actual)
115
Serious AEs
0.9%
Results posted
Mar 2019
Primary outcomePrimary: Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration — 4.35; 7.15 Minutes
◆ Published Evidence
Highly cited
242citations · ~14 / year
Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine.
Summary
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
Linked Publications
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Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration |
4.35; 7.15 | — |
| SECONDARY Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration |
6.13; 11.03 | — |
| SECONDARY Level of Consciousness: Number of Participants Awake and Oriented |
8; 13; 19; 33 | — |
| SECONDARY Level of Consciousness: Number of Participants Arousable With Minimal Stimulation |
7; 15; 1; 2 | — |
| SECONDARY Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation |
5; 7; 0; 0 | — |
| SECONDARY Number of Participants Able to Perform 5-Second Head Lift |
13; 24; 20; 35 | — |
| SECONDARY Number of Participants Experiencing General Muscle Weakness |
2; 3; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
- 18 to 65 years of age (inclusive);
- Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
- Scheduled for surgery in supine position;
- Body mass index (BMI) 6 months), IUD, abstinence];
- Has already participated in a sugammadex trial including Protocol 19.4.303.
Data sourced from ClinicalTrials.gov (NCT00474253) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.