Perioperative Lignocaine and Sleep Disturbance

Study Overview
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Brief Summary
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The aim of this clinical trial is to study the effect of an intravenous infusion of lidocaïne in a multimodal analgesic protocol on the architecture sleep during the first postoperative night.

Detailed Description
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To study the effect of lidocaïne, we plan to include 40 patients, randomized in 2 groups, undergoing open prostate surgery in this randomized placebo-controlled trial. Before anesthesia induction, these patients receive an intravenous lidocaine infusion (bolus 1,5 mg.kg-1 followed by a continuous infusion of 2mg.kg-1.h during 24 hours) or an equal volume of placebo. Then the anesthesia is induced with propofol, sufentanil et rocuronium. The postoperative analgesia is provided by paracetamol, tramadol and patient-controlled analgesia (PCA) with morphine or oral oxycodone. A polysomnography is registred on the preoperative night and on the first postoperative night.

Official Title
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Effect of Peroperative Intravenous Infusion of Lignocaine on the Quality of Postoperative Sleep

Conditions
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Sleep Disturbance

Intervention / Treatment
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* Drug: Lidocaïne 2%
* Drug: Placebo (for Lidocaïne)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radical prostatectomy Exclusion Criteria: BMI > 30 Neurologic/psychiatric diseases or therapeutics, seizyres Cardiac disease, second or third degree atrioventricular block Obstructive sleep apnea syndrome History of liver or renal insufficiency and any contraindication to the anesthetic protocol of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaïne 2%<br>Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h | Drug: Lidocaïne 2%<br>* Continuous infusion during per and postoperative periods<br>* Other names: Linisol;|
| Placebo Comparator: Placebo (for Lidocaïne)<br>Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h | Drug: Placebo (for Lidocaïne)<br>* Continuous infusion during per and postoperative periods<br>* Other names: NaCl 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep |  | Postoperaty day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latence |  | Postoperaty day 1 | 
| Sleep time |  | Postoperaty day 1 | 
| Cumulative Opioid use |  | Postoperaty day 1 | 
| Quality of analgesia (Visual Analogic Scale) |  | Postoperaty day 1 |