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NCT Number: NCT01441843

Resistance Under the Microscope

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasmus University Medical Center

Rotterdam, 3015CE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorazepam

Drug

Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery

Other names: Temesta

NaCl 0.9% (Sodium Chloride)

Drug

Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery

Other names: NaCl 0.9%

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2011
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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