The Effects of Midazolam on the Quality of Postoperative Recovery

Depression Clinical Trial

— WOLII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993459
• Other study ID #: 14091991
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2013
• Last updated: January 24, 2016
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Ministry of Health, Welfare and SportNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patie¨nts 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Anxiety
• Depression
• Fatigue
• Postoperative Period

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Centre	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Recovery (QoR-40 Scale)		baseline, workday 3 postoperative, workday 7 postoperative	No
Secondary	Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)		baseline, workday 1 postoperative, workday 7 postoperative	No
Secondary	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	No
Secondary	Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)		baseline, workday 7 postoperative	No
Secondary	Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).		baseline, workday 7 postoperative	No
Secondary	Change in Systolic bloodpressure		baseline, workday 1 postoperative	No
Secondary	Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)		baseline, workday 7 postoperative	No
Secondary	Change in Diastolic Blood pressure		baseline, workday 1 postoperative	No
Secondary	Temperature after surgery measured with an ear thermometer		directly after surgery	No
Secondary	Change in Heart Rate		preoperatively, during surgery and postoperatively	No