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Resistance Under the Microscope

Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety

Intervention: Lorazepam (Drug); NaCl 0.9% (Sodium Chloride) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
Markus Klimek, MD, PhD, Principal Investigator, Affiliation: Erasmus Medical Center


The purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Quality of Recovery Score

Secondary outcome:



Aggression Regulation

Depressive Mood

Somatic Symptoms and Complaints

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: October 2010
Last updated: January 27, 2014

Page last updated: August 23, 2015

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