Resistance Under the Microscope

NCT ID: NCT01441843

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-09-30

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lorazepam

Lorazepam 4mg/4ml

Group Type: ACTIVE_COMPARATOR

Lorazepam

Intervention Type: DRUG

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

NaCl 0.9%

NaCl 0.9% 4ml

Group Type: PLACEBO_COMPARATOR

NaCl 0.9% (Sodium Chloride)

Intervention Type: DRUG

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

Interventions

Lorazepam

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

Intervention Type: DRUG

NaCl 0.9% (Sodium Chloride)

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

Intervention Type: DRUG

Other Intervention Names

Temesta; NaCl 0.9%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Markus Klimek

Vice-head of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Klimek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus University Medical Center

Rotterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: RESULT

PMID: 23635914 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27282374 (View on PubMed)

Other Identifiers

NL3253507810

Identifier Type: -

Identifier Source: org_study_id