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

Erasmus Medical Center1 site in 1 country192 target enrollmentFebruary 2014

ConditionsPostoperative Period Anxiety Fatigue Depression Aggression

InterventionsMidazolam NaCl (sodium chloride) 0,9%

DrugsMidazolam NaCl (sodium chloride) 0,9%

Overview

Phase: Phase 4
Intervention: Midazolam
Conditions: Postoperative Period
Sponsor: Erasmus Medical Center
Enrollment: 192
Locations: 1
Primary Endpoint: Change in Quality of Recovery (QoR-40 Scale)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

October 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Erasmus Medical Center

Responsible Party

Principal Investigator

Stefan van Beek

BSc

Erasmus Medical Center

Eligibility Criteria

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

Arms & Interventions

Midazolam intravenous

3mg/ml midazolam given intravenously

Intervention: Midazolam

NaCl (sodium chloride) 0,9%

NaCl (sodium chloride) 0,9% given intravenously 3ml.

Intervention: NaCl (sodium chloride) 0,9%

Outcomes

Primary Outcomes

Change in Quality of Recovery (QoR-40 Scale)

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

Secondary Outcomes

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