Aggression, Anxiety, Depression, Fatigue, Postoperative Period
Conditions
Keywords
Quality of Recovery
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.
Interventions
DRUGMidazolam
We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery
DRUGNaCl (sodium chloride) 0,9%
We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Quality of Recovery (QoR-40 Scale) | baseline, workday 3 postoperative, workday 7 postoperative |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : Multidimensionele Vermoeidheids Index (MVI-20) | baseline, workday 7 postoperative |
| Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES). | baseline, workday 7 postoperative |
| Change in Systolic bloodpressure | baseline, workday 1 postoperative |
| Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI) | baseline, workday 1 postoperative, workday 7 postoperative |
| Change in Diastolic Blood pressure | baseline, workday 1 postoperative |
| Temperature after surgery measured with an ear thermometer | directly after surgery |
| Change in Heart Rate | preoperatively, during surgery and postoperatively |
| Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES) | baseline, workday 7 postoperative |
Countries
Netherlands
Outcome results
None listed