Post-operative sleep after open prostate surgery
Conditions
Interventions
Trade Name: Linisol
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
CHU of Liege
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: Combined surgery OSA syndrome Preoperative use of psychotropic medication Contraindication to any medication included in the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Post-operative analgesia ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Post-operative opioid consumption Post-operative fatigue;Timepoint(s) of evaluation of this end point: End of first post-operative night | — |
Countries
Belgium
Contacts
Public ContactSecretary of the department
Department of anaesthesia and intensive care medicine. CHU of Liege
Outcome results
None listed