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Resistance Under the Microscope

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Erasmus University

Status and phase

Completed
Phase 4

Conditions

Anxiety

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01441843
NL3253507810

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

400 participants in 2 patient groups, including a placebo group

Lorazepam
Active Comparator group
Description:
Lorazepam 4mg/4ml
Treatment:
Drug: Lorazepam
NaCl 0.9%
Placebo Comparator group
Description:
NaCl 0.9% 4ml
Treatment:
Drug: NaCl 0.9% (Sodium Chloride)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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