The Effects of Midazolam on the Quality of Postoperative Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Postoperative Period Anxiety Fatigue Depression Aggression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Midazolam intravenous

3mg/ml midazolam given intravenously

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

NaCl (sodium chloride) 0,9%

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

Group Type PLACEBO_COMPARATOR

NaCl (sodium chloride) 0,9%

Intervention Type DRUG

We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery

Interventions

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Midazolam

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

Intervention Type DRUG

NaCl (sodium chloride) 0,9%

We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery

Intervention Type DRUG

Other Intervention Names

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Dormicum saline solution sodium chloride solution

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