NCT04260685

Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

Intraoperative Lidocaine Versus Esmolol Infusion for Optimizing Surgical Field Visibility During Lumbar Discectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Intra-operative blood loss is an important attribution and predictor of the lumbar spine surgery and patient outcome. Stripping the muscle off bone makes more exposed bleeding spine surface is one of causes for blood loss during lumbar surgeries. The importance to decrease the bleeding is to improve the surgical field visibility which provides technical ease for surgeon and decreases the surgical time besides maintaining the hemodynamic stability. In past, there were many trials to minimize surgical blood loss by different drugs such as Na Nitroprusside, magnesium sulfate, volatile anesthetics and beta-adrenergic antagonist.

Detailed description

Sample size: Assuming mean and standard deviation of mean arterial pressure in lidocaine group versus esmolol group is 90±27.9 versus 73± 22.5 so the sample size will be 70 (35 in each group ) using Open Epi program with confidence level 95%, power of test 80% All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every participant. All patients will be kept nil orally 6 hours before the operation. All surgeries will be done by the same surgeon to decrease observer's bias. The surgeon and the outcome assessor (anesthesiologist collect the data) will be blinded to study drugs. Using computer generated randomization table, each group consists of 35 patients.

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
DRUG	Lidocaine	IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h
DRUG	Esmolol	IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min

Timeline

• Start date: 2020-02-04
• Primary completion: 2020-06-15
• Completion: 2020-06-30
• First posted: 2020-02-07
• Last updated: 2020-07-02

Locations

1 site across 1 country: Egypt