Resistance Under the Microscope

Phase 4

Completed

Conditions: Anxiety

Interventions: Drug: NaCl 0.9% (Sodium Chloride)
Drug: Lorazepam

Registration Number: NCT01441843

Lead Sponsor: Erasmus Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 400

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9%	NaCl 0.9% (Sodium Chloride)	NaCl 0.9% 4ml
Lorazepam	Lorazepam	Lorazepam 4mg/4ml

Primary Outcome Measures

Name	Time	Method
Quality of Recovery Score	Baseline; first postoperative working day; seventh postoperative day.	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.

Secondary Outcome Measures

Name	Time	Method
Fatigue	baseline; 1 week after surgery	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.
Anxiety	baseline; after surgery but before discharge; 1 week after surgery	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.
Aggression Regulation	baseline; 1 week after surgery	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
Somatic Symptoms and Complaints	Baseline; first postoperative working day; 1 week after surgery	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.
Depressive Mood	baseline; 1 week after surgery	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.