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Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00535743
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

Condition or disease Intervention/treatment Phase
Anesthesia, General Drug: Sugammadex Drug: Placebo Drug: Esmeron® Phase 2

Detailed Description:
In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Safety Assessor-Blinded, Placebo- Controlled, Phase II, Parallel Dose-Finding Trial in Subjects of ASA 1-3 to Assess the Efficacy and Safety of 5 Doses of Sugammadex Administered at 3 and 15 Minutes After Administration of 1.0 and 1.2 mg/kg Rocuronium Bromide
Actual Study Start Date : March 4, 2004
Actual Primary Completion Date : July 20, 2004
Actual Study Completion Date : July 20, 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Arm A. Placebo; 3 min after 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Placebo
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
Other Name: NaCl 0.9%

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Placebo Comparator: Arm G. Placebo; 15 min after 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Placebo
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
Other Name: NaCl 0.9%

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Placebo Comparator: Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Placebo
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
Other Name: NaCl 0.9%

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Placebo Comparator: Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Placebo
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
Other Name: NaCl 0.9%

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide

Experimental: Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Other Names:
  • Org 25969
  • MK-8616
  • BRIDION®

Drug: Esmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other Names:
  • Zemuron®
  • Rocuronium bromide




Primary Outcome Measures :
  1. Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 [ Time Frame: Up to 240 minutes following administration of study treatment ]
    Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).


Secondary Outcome Measures :
  1. Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 [ Time Frame: Up to 200 minutes following administration of study treatment ]
    Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

  2. Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 [ Time Frame: Up to 180 minutes following administration of study treatment ]
    Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

  3. Number of Participants Experiencing an Adverse Event [ Time Frame: Up to 7 days following administration of study treatment ]
    The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants of ASA class 1 - 3, above or equal to the age of 18 years;
  • Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
  • Participants scheduled for surgical procedures in supine position;
  • Participants who had given written informed consent.

Exclusion Criteria:

  • Participants in whom a difficult intubation because of anatomical malformations was expected;
  • Participants known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction;
  • Participants known or suspected to have a (family) history of malignant hyperthermia;
  • Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
  • Participants receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg^2+;
  • Participants who had already participated in this trial;
  • Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial;
  • Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;
  • Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence;
  • Female participants who were breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535743


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00535743    
Other Study ID Numbers: P05944
19.4.206 ( Other Identifier: Organon Protocol Number )
MK-8616-024 ( Other Identifier: Merck Protocol Number )
First Posted: September 26, 2007    Key Record Dates
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
Layout table for MeSH terms
Bromides
Rocuronium
Anticonvulsants
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs