Perioperative Lignocaine and Sleep Disturbance

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03317912
• Other study ID #: ULiege
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: October 17, 2017
• Start date: December 2017
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: University Hospital of Liege
• Contact: Isabelle Maquoi
• Phone: 32 4 366 7179
• Email: i.maquoi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Drug:
• Lidocaïne 2%
Continuous infusion during per and postoperative periods
• Placebo (for Lidocaïne)
Continuous infusion during per and postoperative periods

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

References & Publications (2)

Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. — View Citation

Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep		Postoperaty day 1
Secondary	Sleep latence		Postoperaty day 1
Secondary	Sleep time		Postoperaty day 1
Secondary	Cumulative Opioid use		Postoperaty day 1
Secondary	Quality of analgesia (Visual Analogic Scale)		Postoperaty day 1