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
Summary
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: AnxietyFatigue 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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