NCT01441843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4 anxiety

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 10, 2014

Completed
Last Updated

September 25, 2023

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

September 22, 2011

Results QC Date

August 29, 2013

Last Update Submit

September 6, 2023

Conditions

Anxiety

Keywords

quality of lifelorazepamanxietypremedicationsurgeryAdult patientsAmbulatory Surgical ProceduresPostoperative Period

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery Score

    The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery. Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery.

    Baseline; first postoperative working day; seventh postoperative day.

Secondary Outcomes (5)

  • Anxiety

    baseline; after surgery but before discharge; 1 week after surgery

  • Fatigue

    baseline; 1 week after surgery

  • Aggression Regulation

    baseline; 1 week after surgery

  • Depressive Mood

    baseline; 1 week after surgery

  • Somatic Symptoms and Complaints

    Baseline; first postoperative working day; 1 week after surgery

Study Arms (2)

Lorazepam

ACTIVE COMPARATOR

Lorazepam 4mg/4ml

Drug: Lorazepam

NaCl 0.9%

PLACEBO COMPARATOR

NaCl 0.9% 4ml

Drug: NaCl 0.9% (Sodium Chloride)

Interventions

LorazepamDRUG

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

Also known as: Temesta
Lorazepam
NaCl 0.9% (Sodium Chloride)DRUG

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

Also known as: NaCl 0.9%
NaCl 0.9%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients \> 18 years admitted to the Day-Case Surgery Department Erasmus MC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus University Medical Center

Rotterdam, 3015CE, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 23635914RESULT

  • 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.

    PMID: 27282374DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

LorazepamSodium Chloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. M. Klimek
Organization
Erasmus University Medical Centre
m.klimek@erasmusmc.nl
+31107033713

Study Officials

  • Markus Klimek, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-head of Anesthesiology

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 28, 2011

Study Start

October 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 25, 2023

Results First Posted

March 10, 2014

Record last verified: 2018-02

Locations

NL(1)