Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex

July 18, 2017 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois
Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VAud
      • Lausanne, VAud, Switzerland, 1011
        • Lausanne University hospital

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:

  • patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures

Exclusion Criteria:

  • contraindication to dexamethasone administration
  • contraindication to sugammadex administration
  • contraindication to rocuronium administration

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No IV dexamethasone
Patients will receive an equivalent volume of normal saline.
Drug: Normal saline
Experimental: IV dexamethasone
Patients will receive 0.1 mg/kg of dexamethasone.
Drug: IV dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean recovery time for T4/T1 ratio > 90% after sugammadex administration
Time Frame: surgical procedure
surgical procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean recovery time for T4/T1 ratio > 80% after sugammadex administration
Time Frame: surgical procedure
surgical procedure
Mean recovery time for T4/T1 ratio > 70% after sugammadex administration
Time Frame: surgical procedure
surgical procedure

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Vaudois

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

June 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 478/14

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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