Perioperative Lignocaine and Sleep Disturbance

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03317912

Enrollment

Registered

2017-10-23

Start date

2017-12-31

Completion date

2018-12-31

Last updated

2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disturbance

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.

Interventions

DRUGLidocaïne 2%

Continuous infusion during per and postoperative periods

DRUGPlacebo (for Lidocaïne)

Continuous infusion during per and postoperative periods

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Contacts

Primary ContactIsabelle Maquoi

i.maquoi@gmail.com32 4 366 7179

Backup ContactGregory Hans

32 4 366 7179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026