Resistance Under the Microscope

Study Overview
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Brief Summary
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The purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery. This study data will also be used for further research aiming to identify vulnerable patients in the day-case surgery setting.

Detailed Description
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Since the early 1980s, the investigators have seen a shift towards day-case surgery. Before surgery, many patients have negative feelings about the surgical procedure. These anxieties have various negative effects. To reduce this resistance preoperative administration of an anxiolytic drug is administered, typically a benzodiazepine. The investigators know that benzodiazepines are effective in reducing anxiety, but up to now there is nog good scientific evidence about the effectiveness of lorazepam on the quality of recovery in day-case surgery patients. The ultimate goal of our research project is to identify patients who would benefit from preoperative benzodiazepine administration and who not. Identification would substantially contribute to optimal medical decision making.

Official Title
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Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Lorazepam
* Drug: NaCl 0.9% (Sodium Chloride)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients > 18 years admitted to the Day-Case Surgery Department Erasmus MC Exclusion Criteria: insufficient command of the Dutch language ophthalmology surgery Extracorporeal Shock Wave Lithotripsy (ESWL)-, Gastrointestinal endoscopic intervention, Botox-, Abortion and Pain treatment Use of psychopharmaceuticals Contra-indication of lorazepam use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lorazepam<br>Lorazepam 4mg/4ml | Drug: Lorazepam<br>* Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery<br>* Other names: Temesta;|
| Placebo Comparator: NaCl 0.9%<br>NaCl 0.9% 4ml | Drug: NaCl 0.9% (Sodium Chloride)<br>* Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery<br>* Other names: NaCl 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery Score | The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery. Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery. | Baseline; first postoperative working day; seventh postoperative day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | The State-Trait Anxiety Inventory (STAI) is used to assess anxiety. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of anxiety. | baseline; after surgery but before discharge; 1 week after surgery | 
| Fatigue | The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of fatigue. | baseline; 1 week after surgery | 
| Aggression Regulation | The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of aggression | baseline; 1 week after surgery | 
| Depressive Mood | The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of depression. | baseline; 1 week after surgery | 
| Somatic Symptoms and Complaints | Medical records are used to assess somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure somatic symptoms and complaints. | Baseline; first postoperative working day; 1 week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, lorazepam, anxiety, premedication, surgery, Adult patients, Ambulatory Surgical Procedures, Postoperative Period