Perioperative Lignocaine and Sleep Disturbance

University of Liege

Status and phase: Unknown; Phase 4

Conditions: Sleep Disturbance

Treatments: Drug: Placebo (for Lidocaïne); Drug: Lidocaïne 2%

Study type: Interventional

Funder types: Other

Identifiers

NCT03317912

ULiege

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Lidocaïne 2%

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaïne 2%

Placebo (for Lidocaïne)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (for Lidocaïne)