Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

Zagazig University

Status and phase: Completed; Phase 2

Conditions: Lumbar Disc Herniation

Treatments: Drug: Esmolol; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04260685

5901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• American society of anesthesiologist( ASA): I& II Physical status:
• Body Mass Index( BMI)=(25-35 kg/m2).
• Type of operations: lumbar discectomy.
• Written informed consent from the patient.

Exclusion criteria

• Patient refusal.
• .Altered mental state
• . Patients on beta-blockers or with a known history of allergy to study drugs.
• Hepatic, renal, Cardiovascular and respiratory diseases.
• Diabetic patients.
• Patients receiving anticoagulants.
• Previous spine surgery

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

lidocaine

Active Comparator group

Description:

the Patient will receive IV bolus of 1.5mg/kg lidocaine 1% over ten minutes followed by continuous infusion of 1.5mg/kg/h

Treatment:

Drug: Lidocaine

esmolol

Active Comparator group

Description:

the Patient will receive IV bolus of esmolol 0.5 mg/kg over ten minutes followed by continuous infusion of 100-300 ug/kg/min

Treatment:

Drug: Esmolol