Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101) (DANCHEONG)

June 1, 2017 updated by: Merck Sharp & Dohme LLC

A Randomized Safety-Assessor Blinded Trial Comparing Sugammadex With Neostigmine in Korean Subjects Scheduled for Surgeries Requiring Moderate Neuromuscular Blockade

This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists Class 1 or 2 or 3
  • >=18 years of age and of either sex
  • scheduled for elective surgical procedure under general anesthesia requiring the use of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade in a supine position allowing neuromuscular transmission monitoring and requiring reversal of neuromuscular blockade
  • Korean descent born in Korea, never emigrated out of Korea, and have a Korean home address

Exclusion Criteria:

  • expected difficult intubation due to anatomic malformations
  • expected transfer to intensive care unit after surgery
  • neuromuscular disorders affecting neuromuscular blockade
  • significant hepatic or renal dysfunction
  • require use of pneumatic tourniquet during surgery
  • (family) history of malignant hyperthermia
  • allergy to cyclodextrins (including sugammadex) or other medication(s) used during general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug administration; contraindication to use of neostigmine or glycopyrrolate

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugammadex
Drug: sugammadex
sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion
Other Names:
  • SCH 900616; Bridion
Active Comparator: Neostigmine
Drug: neostigmine
neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion
Other Names:
  • neostigmine methylsulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9
Time Frame: From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (height) of the 1st & 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated complete recovery.
From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)

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)

February 1, 2010

Primary Completion (Actual)

August 20, 2010

Study Completion (Actual)

August 20, 2010

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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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