Effect of Peroperative Intravenous Infusion of Lignocaine on the Quality of Postoperative Sleep
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- University of Liege
- Enrollment
- 40
- Primary Endpoint
- Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lidocaïne 2%
Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h
Intervention: Lidocaïne 2% (Drug)
Placebo (for Lidocaïne)
Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h
Intervention: Placebo (for Lidocaïne) (Drug)
Outcomes
Primary Outcomes
Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep
Time Frame: Postoperaty day 1
Secondary Outcomes
- Cumulative Opioid use(Postoperaty day 1)
- Sleep latence(Postoperaty day 1)
- Sleep time(Postoperaty day 1)
- Quality of analgesia (Visual Analogic Scale)(Postoperaty day 1)
Investigators
Jean François Brichant
Professor
University of Liege