Perioperative Lignocaine and Sleep Disturbance
Effect of Peroperative Intravenous Infusion of Lignocaine on the Quality of Postoperative Sleep
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2017
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 23, 2017
October 1, 2017
1 year
March 31, 2015
October 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep
Postoperaty day 1
Secondary Outcomes (4)
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
Study Arms (2)
Lidocaïne 2%
ACTIVE COMPARATORBolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h
Placebo (for Lidocaïne)
PLACEBO COMPARATORBolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h
Interventions
Continuous infusion during per and postoperative periods
Continuous infusion during per and postoperative periods
Eligibility Criteria
You may qualify if:
- Radical prostatectomy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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. doi: 10.1097/00000542-200701000-00007.
PMID: 17197840RESULTKrenk 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.
PMID: 24634631RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle Maquoi
CHU Liege - Department of Anesthesia and Intensive Care Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 31, 2015
First Posted
October 23, 2017
Study Start
December 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 23, 2017
Record last verified: 2017-10