Resistance Under the Microscope

Overview

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.

Full Title of Study: “Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2011

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.

Interventions

  • Drug: Lorazepam
    • Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery
  • Drug: NaCl 0.9% (Sodium Chloride)
    • Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery

Arms, Groups and Cohorts

  • Active Comparator: Lorazepam
    • Lorazepam 4mg/4ml
  • Placebo Comparator: NaCl 0.9%
    • NaCl 0.9% 4ml

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Recovery Score
    • Time Frame: 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 Measures

  • Anxiety
    • Time Frame: 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.
  • Fatigue
    • Time Frame: 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.
  • Aggression Regulation
    • Time Frame: 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
  • Depressive Mood
    • Time Frame: 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.
  • Somatic Symptoms and Complaints
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasmus Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Markus Klimek, Vice-head of Anesthesiology – Erasmus Medical Center
  • Overall Official(s)
    • Markus Klimek, MD, PhD, Principal Investigator, Erasmus Medical Center

Citations Reporting on Results

Mijderwijk H, van Beek S, Klimek M, Duivenvoorden HJ, GrĂ¼ne F, Stolker RJ. Lorazepam does not improve the quality of recovery in day-case surgery patients: a randomised placebo-controlled clinical trial. Eur J Anaesthesiol. 2013 Dec;30(12):743-51. doi: 10.1097/EJA.0b013e328361d395.

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