Phase 4
N=400
Resistance Under the Microscope
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT01441843 ↗Enrolled (actual)
400
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Quality of Recovery Score — 172.8; 176.3; 174.5; 176.4 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lorazepam (Drug); NaCl 0.9% (Sodium Chloride) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erasmus Medical Center
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Recovery Score |
172.8; 176.3; 174.5; 176.4; 177.2; 180.4 | — |
| SECONDARY Anxiety |
— | — |
| SECONDARY Fatigue |
— | — |
| SECONDARY Aggression Regulation |
— | — |
| SECONDARY Depressive Mood |
— | — |
| SECONDARY Somatic Symptoms and Complaints |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01441843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.