Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)

August 18, 2017 updated by: Merck Sharp & Dohme LLC

A Multi-Center Randomized Safety Assessor-Blinded Placebo-Controlled Parallel and Dose Escalating Dose-Finding Trial in Subjects of ASA 1 - 2 to Assess the Safety, Efficacy and PK of Sugammadex Administered at 5 Min. After Administration of 1.2 mg/kg Esmeron

The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1 - 2 between the ages of 18 and 64, inclusive
  • Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
  • Scheduled for surgery in supine position
  • Given written informed consent

Exclusion Criteria:

  • Subjects in whom a difficult intubation because of anatomical malformations was expected
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction
  • Subjects known or suspected to have a (family) history of malignant hyperthermia
  • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
  • Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
  • Subjects who had already participated in CT 19.4.205
  • Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
  • Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
  • Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), IUD, abstinence
  • Subjects giving breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
rocuronium + 16.0 mg/kg Org 25969
Drug: Placebo

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered
Experimental: 2
rocuronium + 2.0 mg/kg Org 25969
Drug: sugammadex

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Other Names:
  • Org 25969
Experimental: 3
rocuronium + 4.0 mg/kg Org 25969
Drug: sugammadex

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Other Names:
  • Org 25969
Experimental: 4
rocuronium + 8.0 mg/kg Org 25969
Drug: sugammadex

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Other Names:
  • Org 25969
Experimental: 5
rocuronium + 12.0 mg/kg Org 25969
Drug: sugammadex

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Other Names:
  • Org 25969

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.
Time Frame: After administration of rocuronium
After administration of rocuronium

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.
Time Frame: After administration of rocuronium
After administration of rocuronium

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2003

Primary Completion (Actual)

July 14, 2004

Study Completion (Actual)

July 14, 2004

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 21, 2006

First Posted (Estimate)

September 22, 2006

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • P05942
  • 19.4.205

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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