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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-07

Study Completion Date

2007-03-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sugammadex + Sevoflurane

After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

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

Sevoflurane

Intervention Type DRUG

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

Sugammadex + Propofol

After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

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

Interventions

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Sugammadex

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

Intervention Type DRUG

Rocuronium

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

Intervention Type DRUG

Sevoflurane

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Other Intervention Names

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Org 25969 MK-8616 Esmeron® Rocuronium Bromide Ultane® Diprivan®

Eligibility Criteria

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Inclusion Criteria

* Participants at least 20 years but under 65 years of age;
* Participants of American Society of Anesthesiologists (ASA) class 1-3;
* Participants scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;
* Participants scheduled for a surgical procedure in supine position;
* Participants who had given written informed consent.

Exclusion Criteria

* Participants in whom difficult intubation was expected because of anatomical malformations;
* Participants known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;
* Participants known or suspected to have a (family) history of malignant hyperthermia;
* Participants known or suspected to have an allergy to medications used during general anesthesia;
* Participants receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg\^2+; based on the dose and time of administration;
* Pregnant or lactating females;
* Female participants of childbearing potential not using any birth control or using only hormonal contraception as birth control;
* Participants who had already participated in trial CT 19.4.312, or in another trial with sugammadex;
* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No