The Effects of Midazolam on the Quality of Postoperative Recovery

Phase 4

Completed

• Conditions: Anxiety; Fatigue; Postoperative Period; Aggression; Depression
• Interventions: Drug: NaCl (sodium chloride) 0,9%; Drug: Midazolam

• Registration Number: NCT01993459
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Study Start: 2014-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-24
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl (sodium chloride) 0,9%	NaCl (sodium chloride) 0,9%	NaCl (sodium chloride) 0,9% given intravenously 3ml.
Midazolam intravenous	Midazolam	3mg/ml midazolam given intravenously

Primary Outcome Measures

Name	Time	Method
Change in Quality of Recovery (QoR-40 Scale)	baseline, workday 3 postoperative, workday 7 postoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Erasmus Medical Centre; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands