Skip to main content
OpenTrials
Completed

NCT Number: NCT01993459

The Effects of Midazolam on the Quality of Postoperative Recovery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Period Aberrant Motor Behavior in Dementia Aggression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Fatigue Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasmus Medical Centre

Rotterdam, South Holland, 3000CA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery

Other names: Dormicum

NaCl (sodium chloride) 0,9%

Drug

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

Primary outcomes

  1. Change in Quality of Recovery (QoR-40 Scale)

    Time frame: baseline, workday 3 postoperative, workday 7 postoperative

Secondary outcomes

  1. Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)

    Time frame: baseline, workday 1 postoperative, workday 7 postoperative

  2. 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

  3. Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)

    Time frame: baseline, workday 7 postoperative

  4. Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).

    Time frame: baseline, workday 7 postoperative

  5. Change in Systolic bloodpressure

    Time frame: baseline, workday 1 postoperative

  6. Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)

    Time frame: baseline, workday 7 postoperative

  7. Change in Diastolic Blood pressure

    Time frame: baseline, workday 1 postoperative

  8. Temperature after surgery measured with an ear thermometer

    Time frame: directly after surgery

  9. Change in Heart Rate

    Time frame: preoperatively, during surgery and postoperatively

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: WOLII

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.