Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium

August 16, 2022 updated by: Kreiskrankenhaus Dormagen
The aim of the present study is to compare the time course of a neuromuscular block in patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting several hours before surgery with patients receiving the drug immediately before induction of anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

108

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

  • Germany
      • Dormagen, Germany, D-51375
        • Kreiskrankenhaus Dormagen

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients of a primary care clinic undergoing elective gynecologic abdominal surgery

Description

Inclusion Criteria:

  • patients aged 18 to 65 years,
  • American Society of Anesthesiologists Physical Status I or II,
  • 50-90 kg body weight,
  • undergoing elective laparoscopic gynaecological surgery in general anaesthesia necessitating intraoperative neuromuscular blockade.

Exclusion Criteria:

  • expected difficulties with endotracheal intubation (history of difficult intubation,
  • reduced opening of the mouth (< 2cm), and Mallampati Score of 4),
  • increased risk of pulmonary aspiration (gastrooesophageal reflux, full stomach, intestinal obstruction),
  • known allergies to the drugs tested,
  • pregnancy,
  • neuromuscular disorders,
  • intake of drugs affecting neuromuscular blockade, such as furosemide, magnesium or cephalosporins,
  • hepatic-or renal insufficiency.

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
dexamethasone late
dexamethasone during induction of anesthesia
no dexamethasone
no dexamethasone during measurements
dexamethasone early
dexamethasone before induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.
Time Frame: one hour
one hour

Collaborators and Investigators

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

Sponsor

Kreiskrankenhaus Dormagen

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

December 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • dexarelax

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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