Resistance Under the Microscope

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441843
• Other study ID #: NL3253507810
• Status: Completed
• Phase: Phase 4
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2018
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Mijderwijk H, van Beek S, Klimek M, Duivenvoorden HJ, Grune 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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