Clinical trial NCT01441843: Resistance Under the Microscope
Official title: Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety
Keywords: quality of life
lorazepam
anxiety
premedication
surgery
Adult patients
Ambulatory Surgical Procedures
Postoperative Period
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Quality of Recovery Score
timeFrame: Baseline; first postoperative working day; seventh postoperative day.
Secondary outcomes:
measure: Anxiety
timeFrame: baseline; after surgery but before discharge; 1 week after surgery
measure: Fatigue
timeFrame: baseline; 1 week after surgery
measure: Aggression Regulation
timeFrame: baseline; 1 week after surgery
measure: Depressive Mood
timeFrame: baseline; 1 week after surgery
measure: Somatic Symptoms and Complaints
timeFrame: Baseline; first postoperative working day; 1 week after surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Markus Klimek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1097/EJA.0b013e328361d395.
citation: Mijderwijk H, Stolker RJ, Duivenvoorden HJ, Klimek M, Steyerberg EW. Clinical prediction model to identify vulnerable patients in ambulatory surgery: towards optimal medical decision-making. Can J Anaesth. 2016 Sep;63(9):1022-32. doi: 10.1007/s12630-016-0673-3. Epub 2016 Jun 9.