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The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam intravenous | Experimental | 3mg/ml midazolam given intravenously |
|
| NaCl (sodium chloride) 0,9% | Placebo Comparator | NaCl (sodium chloride) 0,9% given intravenously 3ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Recovery (QoR-40 Scale) | baseline, workday 3 postoperative, workday 7 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI) | baseline, workday 1 postoperative, workday 7 postoperative | |
| Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jan Stolker, MD, PhD | Erasmus MC Rotterdam Anesthesiology | Study Chair |
| Markus Klimek, MD, PhD | Erasmus MC Rotterdam Anesthesiology | Study Chair |
| Stefan van Beek, BSc | Erasmus MC Rotterdam Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Centre | Rotterdam | South Holland | 3000CA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31576513 | Derived | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D005221 | Fatigue |
| D003863 | Depression |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| NaCl (sodium chloride) 0,9% | Drug | We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery |
|
|
| 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 self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES) | baseline, 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 |
| D001519 | Behavior |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D012919 | Social Behavior |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |