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

Primary Purpose

Postoperative Period, Anxiety, Fatigue

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Midazolam
NaCl (sodium chloride) 0,9%
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Period focused on measuring Quality of Recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Erasmus Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Midazolam intravenous

NaCl (sodium chloride) 0,9%

Arm Description

3mg/ml midazolam given intravenously

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

Outcomes

Primary Outcome Measures

Change in Quality of Recovery (QoR-40 Scale)

Secondary Outcome Measures

Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)
Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS)
Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)
Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).
Change in Systolic bloodpressure
Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)
Change in Diastolic Blood pressure
Temperature after surgery measured with an ear thermometer
Change in Heart Rate

Full Information

First Posted
October 29, 2013
Last Updated
January 24, 2016
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01993459
Brief Title
The Effects of Midazolam on the Quality of Postoperative Recovery
Acronym
WOLII
Official Title
A Randomized Controlled Trial on the Effects of Midazolam on the Quality of Postoperative Recovery in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Period, Anxiety, Fatigue, Depression, Aggression
Keywords
Quality of Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midazolam intravenous
Arm Type
Experimental
Arm Description
3mg/ml midazolam given intravenously
Arm Title
NaCl (sodium chloride) 0,9%
Arm Type
Placebo Comparator
Arm Description
NaCl (sodium chloride) 0,9% given intravenously 3ml.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum
Intervention Description
We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery
Intervention Type
Drug
Intervention Name(s)
NaCl (sodium chloride) 0,9%
Other Intervention Name(s)
saline solution, sodium chloride solution
Intervention Description
We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery
Primary Outcome Measure Information:
Title
Change in Quality of Recovery (QoR-40 Scale)
Time Frame
baseline, workday 3 postoperative, workday 7 postoperative
Secondary Outcome Measure Information:
Title
Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)
Time Frame
baseline, workday 1 postoperative, workday 7 postoperative
Title
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
Title
Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)
Time Frame
baseline, workday 7 postoperative
Title
Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).
Time Frame
baseline, workday 7 postoperative
Title
Change in Systolic bloodpressure
Time Frame
baseline, workday 1 postoperative
Title
Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)
Time Frame
baseline, workday 7 postoperative
Title
Change in Diastolic Blood pressure
Time Frame
baseline, workday 1 postoperative
Title
Temperature after surgery measured with an ear thermometer
Time Frame
directly after surgery
Title
Change in Heart Rate
Time Frame
preoperatively, during surgery and postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jan Stolker, MD, PhD
Organizational Affiliation
Erasmus MC Rotterdam Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Markus Klimek, MD, PhD
Organizational Affiliation
Erasmus MC Rotterdam Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefan van Beek, BSc
Organizational Affiliation
Erasmus MC Rotterdam Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Medical Centre
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3000CA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31576513
Citation
van Beek S, Kroon J, Rijs K, Mijderwijk HJ, Klimek M, Stolker RJ. The effect of midazolam as premedication on the quality of postoperative recovery after laparotomy: a randomized clinical trial. Can J Anaesth. 2020 Jan;67(1):32-41. doi: 10.1007/s12630-019-01494-6. Epub 2019 Oct 1.
Results Reference
derived

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The Effects of Midazolam on the Quality of Postoperative Recovery

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