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Perioperative Lignocaine and Sleep Disturbance

Primary Purpose

Sleep Disturbance

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Lidocaïne 2%

Placebo (for Lidocaïne)

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaïne 2%

Placebo (for Lidocaïne)

Arm Description

Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h

Outcomes

Primary Outcome Measures

Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep

Secondary Outcome Measures

Sleep latence

Sleep time

Cumulative Opioid use

Quality of analgesia (Visual Analogic Scale)

Full Information

NCT ID

NCT03317912

First Posted

March 31, 2015

Last Updated

October 17, 2017

Sponsor

University of Liege

1. Study Identification

Unique Protocol Identification Number

NCT03317912

Brief Title

Perioperative Lignocaine and Sleep Disturbance

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2017 (Anticipated)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disturbance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaïne 2%

Arm Type

Active Comparator

Arm Description

Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h

Arm Title

Placebo (for Lidocaïne)

Arm Type

Placebo Comparator

Arm Description

Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h

Intervention Type

Drug

Intervention Name(s)

Lidocaïne 2%

Other Intervention Name(s)

lignocaïne, Linisol

Intervention Description

Continuous infusion during per and postoperative periods

Intervention Type

Drug

Intervention Name(s)

Placebo (for Lidocaïne)

Other Intervention Name(s)

NaCl 0.9%

Intervention Description

Continuous infusion during per and postoperative periods

Primary Outcome Measure Information:

Title

Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep

Time Frame

Postoperaty day 1

Secondary Outcome Measure Information:

Title

Sleep latence

Time Frame

Postoperaty day 1

Title

Sleep time

Time Frame

Postoperaty day 1

Title

Cumulative Opioid use

Time Frame

Postoperaty day 1

Title

Quality of analgesia (Visual Analogic Scale)

Time Frame

Postoperaty day 1

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Isabelle Maquoi

Phone

32 4 366 7179

i.maquoi@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Gregory Hans

Phone

32 4 366 7179

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabelle Maquoi

Organizational Affiliation

CHU Liege - Department of Anesthesia and Intensive Care Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

17197840

Citation

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. doi: 10.1097/00000542-200701000-00007.

Results Reference

result

PubMed Identifier

24634631

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.

Results Reference

result

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Perioperative Lignocaine and Sleep Disturbance

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