Phase 3
Completed N=224
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
Anesthesia, General
Source: ClinicalTrials.gov NCT00298831 ↗
Enrolled (actual)
224
Serious AEs
4.1%
Results posted
Mar 2019
Primary outcomePrimary: Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9 — 2.32 Minutes
◆ Published Evidence
Emerging
2citations · ~0 / year
Sugammadex is effective in reversing rocuronium in the presence of antibiotics.
Summary
The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.
Linked Publications
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Sugammadex is effective in reversing rocuronium in the presence of antibiotics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9 |
2.32 | — |
| SECONDARY Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7 |
1.50 | — |
| SECONDARY Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8 |
1.80 | — |
| SECONDARY Clinical Assessment of Recovery - Participant's Level of Consciousness |
138; 184; 51; 12; 8; 0 | — |
| SECONDARY Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL) |
173; 196 | — |
| SECONDARY Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW) |
4; 9 | — |
Eligibility Criteria
Inclusion criteria
- American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.
Exclusion criteria
- Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
- Participants taking medications known to interfere with neuromuscular blocking agents.
- Participants who are of child-bearing potential, pregnant, and breast feeding
Data sourced from ClinicalTrials.gov (NCT00298831) 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.