The Effects of Midazolam on the Quality of Postoperative Recovery

Phase 4CompletedNCT01993459

Erasmus Medical Center192 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

192

Conditions

Postoperative Period Anxiety Fatigue Depression Aggression

Interventions

MidazolamDRUG

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Erasmus Medical Centre

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

Change in Quality of Recovery (QoR-40 Scale)

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

Secondary Outcomes

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

Time frame: 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

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

Time frame: 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

Change in Systolic bloodpressure

Time frame: 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

Change in Diastolic Blood pressure

Time frame: baseline, workday 1 postoperative

Temperature after surgery measured with an ear thermometer

Time frame: directly after surgery

Change in Heart Rate

Data from ClinicalTrials.gov

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