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Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)

NCT00559468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-11-25

Study results available
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Summary

The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.

Conditions

  • Anesthesia, General

Interventions

DRUG

Sugammadex

Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium

DRUG

Rocuronium

Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium

DRUG

Sevoflurane

Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.

DRUG

Propofol

Propofol IV administered for induction and maintenance of anesthesia, based on randomization.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-07
Primary Completion
2007-03-02
Completion
2007-03-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559468 on ClinicalTrials.gov