The Effects of Midazolam on the Quality of Postoperative Recovery (WOLII)

Erasmus University

Status and phase: Completed; Phase 4

Conditions: Aggression; Postoperative Period; Depression; Fatigue; Anxiety

Treatments: Drug: NaCl (sodium chloride) 0,9%; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01993459

14091991

Details and patient eligibility

About

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

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 2 patient groups, including a placebo group

Midazolam intravenous

Experimental group

Description:

3mg/ml midazolam given intravenously

Treatment:

Drug: Midazolam

NaCl (sodium chloride) 0,9%

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl (sodium chloride) 0,9%