Effet of a continuous infusion of intravenous local aesthetics on the quality of sleep after prostate surgery

Phase 1

• Conditions: Post-operative sleep after open prostate surgery; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-001471-50-BE
• Lead Sponsor: CHU of Liege

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-08
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Age = 18
Open prostatectomy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Combined surgery
OSA syndrome
Preoperative use of psychotropic medication
Contraindication to any medication included in the study protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine wether the intravenous infusion of lidocaine improve the quality and architecture of sleep after open prostate surgery.;Secondary Objective: Post-operative fatigue<br>Post-operative analgesia<br>;Primary end point(s): Proportion of stage III/REM sleep during the first post-operative night;Timepoint(s) of evaluation of this end point: End of first post-operative night

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Post-operative opioid consumption<br>Post-operative fatigue;Timepoint(s) of evaluation of this end point: End of first post-operative night