The Effects of Midazolam on the Quality of Postoperative Recovery (WOLII)

January 24, 2016 updated by: Stefan van Beek, Erasmus Medical Center

A Randomized Controlled Trial on the Effects of Midazolam on the Quality of Postoperative Recovery in Patients

The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

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

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3000CA
        • Erasmus Medical Centre

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:

  • All patiënts operated with a laparotomy in the Erasmus Medical Center of Rotterdam, older than 18 years and planned for a postoperative stay for a minimum of 3 days

Exclusion Criteria:

  • Pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients

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
Experimental: Midazolam intravenous
3mg/ml midazolam given intravenously
Drug: Midazolam
We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery
Other Names:
  • Dormicum
Placebo Comparator: NaCl (sodium chloride) 0,9%
NaCl (sodium chloride) 0,9% given intravenously 3ml.
Drug: NaCl (sodium chloride) 0,9%
We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery
Other Names:
  • saline solution
  • sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of Recovery (QoR-40 Scale)
Time Frame: baseline, workday 3 postoperative, workday 7 postoperative
baseline, workday 3 postoperative, workday 7 postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)
Time Frame: baseline, workday 1 postoperative, workday 7 postoperative
baseline, workday 1 postoperative, workday 7 postoperative
Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline, workday 1 postoperative, workday 7 postoperative
baseline, workday 1 postoperative, workday 7 postoperative
Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)
Time Frame: baseline, workday 7 postoperative
baseline, workday 7 postoperative
Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).
Time Frame: baseline, workday 7 postoperative
baseline, workday 7 postoperative
Change in Systolic bloodpressure
Time Frame: baseline, workday 1 postoperative
baseline, workday 1 postoperative
Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)
Time Frame: baseline, workday 7 postoperative
baseline, workday 7 postoperative
Change in Diastolic Blood pressure
Time Frame: baseline, workday 1 postoperative
baseline, workday 1 postoperative
Temperature after surgery measured with an ear thermometer
Time Frame: directly after surgery
directly after surgery
Change in Heart Rate
Time Frame: preoperatively, during surgery and postoperatively
preoperatively, during surgery and postoperatively

Collaborators and Investigators

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

Sponsor

Erasmus Medical Center

Investigators

  • Study Chair: Robert Jan Stolker, MD, PhD, Erasmus MC Rotterdam Anesthesiology
  • Study Chair: Markus Klimek, MD, PhD, Erasmus MC Rotterdam Anesthesiology
  • Principal Investigator: Stefan van Beek, BSc, Erasmus MC Rotterdam Anesthesiology

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

February 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 24, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14091991

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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