NCT03317912

Perioperative Lignocaine and Sleep Disturbance

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Liege · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disturbance

Interventions

Type	Name	Description
DRUG	Lidocaïne 2%	Continuous infusion during per and postoperative periods
DRUG	Placebo (for Lidocaïne)	Continuous infusion during per and postoperative periods

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-10-23
• Last updated: 2017-10-23