Research with human participants

Overview of medical research in the Netherlands

A Randomized Controlled Trial on the effects of midazolam on the quality of postoperative recovery in patients

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Last updated:

Does Midazolam improve the quality of postoperative recovery

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Interventional

ID

NL-OMON39977

Source

ToetsingOnline

Brief title

The effects of midazolam on the quality of postoperative recovery

Condition

  • Other condition

Synonym

anxiety

Health condition

Anesthesiologisch

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
anxiety, midazolam, postoperative recovery, quality of recovery

Outcome measures

Primary outcome

Quality of postoperative recovery (QoR)

Secondary outcome

Anxiety

Agression

Fatique

Medical fysiological data

Depression

Knowledge on the surgery performed

Somatic symptoms

General Self-Efficacy Scale

Self-Esteem

Background summary

Anxiolytic premedication isn't standard in hospitals. Although a lot of
patiënts are anxious or nervous before an operation. Every person deals
differently with this anxiety and forms a resistance. We hypothesise that
anxiety before an operation influences the quality of postoperative recovery in
a negative way. Therefor by reducing anxiety with a benzodiazepine (known for
reducing anxiety) we think the quality of postoperative recovery will be
better.

Study objective

Does Midazolam improve the quality of postoperative recovery

Study design

Randomized Controlled Trial, Double blinded Placebo Controlled

Intervention

Midazolam (dormicum) 3mg

Study burden and risks

It takes 40 minutes for patiënts to fill in all the questionairres. There are
no risk related to this study.

Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

's-Gravendijkwal 230
Rotterdam 3000CA
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

's-Gravendijkwal 230
Rotterdam 3000CA
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

All patients operated with a laparotomy in Erasmus MC Rotterdam with a planned postoperative stay for min. 3 days in the hospital

Exclusion criteria

pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speeking patients

Design

Study phase :
4
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo
Primary purpose :
Prevention

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
192
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Midazolam
Generic name :
Dormicum
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2012-003680-21-NL
CCMO NL41783.078.12

Date completed :
Actual enrolment :
192