Clinical trial NCT01993459: The Effects of Midazolam on the Quality of Postoperative Recovery
Official title: A Randomized Controlled Trial on the Effects of Midazolam on the Quality of Postoperative Recovery in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Period
Anxiety
Fatigue
Depression
Aggression
Keywords: Quality of Recovery
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Quality of Recovery (QoR-40 Scale)
timeFrame: baseline, workday 3 postoperative, workday 7 postoperative
Secondary outcomes:
measure: Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)
timeFrame: baseline, workday 1 postoperative, workday 7 postoperative
measure: Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, workday 1 postoperative, workday 7 postoperative
measure: Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)
timeFrame: baseline, workday 7 postoperative
measure: Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).
timeFrame: baseline, workday 7 postoperative
measure: Change in Systolic bloodpressure
timeFrame: baseline, workday 1 postoperative
measure: Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)
timeFrame: baseline, workday 7 postoperative
measure: Change in Diastolic Blood pressure
timeFrame: baseline, workday 1 postoperative
measure: Temperature after surgery measured with an ear thermometer
timeFrame: directly after surgery
measure: Change in Heart Rate
timeFrame: preoperatively, during surgery and postoperatively
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
state: Zuid-Holland
Study officials:
affiliation: Erasmus MC Rotterdam Anesthesiology
name: Robert Jan Stolker, MD, PhD
role: STUDY_CHAIR
affiliation: Erasmus MC Rotterdam Anesthesiology
name: Markus Klimek, MD, PhD
role: STUDY_CHAIR
affiliation: Erasmus MC Rotterdam Anesthesiology
name: Stefan van Beek, BSc
role: PRINCIPAL_INVESTIGATOR
References:
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.