The Effects of Midazolam on the Quality of Postoperative Recovery

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

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

Conditions
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Anxiety, Postoperative Period, Fatigue, Depression, Aggression

Intervention / Treatment
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* Drug: Midazolam
* Drug: NaCl (sodium chloride) 0,9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam intravenous<br>3mg/ml midazolam given intravenously | Drug: Midazolam<br>* We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery<br>* Other names: Dormicum;|
| Placebo Comparator: NaCl (sodium chloride) 0,9%<br>NaCl (sodium chloride) 0,9% given intravenously 3ml. | Drug: NaCl (sodium chloride) 0,9%<br>* We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery<br>* Other names: sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI) |  | 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) |  | 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 | 
| 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 | 
| Change in Diastolic Blood pressure |  | baseline, workday 1 postoperative | 
| Temperature after surgery measured with an ear thermometer |  | directly after surgery | 
| Change in Heart Rate |  | preoperatively, during surgery and postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Recovery