Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

NCT ID: NCT04260685

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2020-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

lidocaine

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

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h

esmolol

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

Group Type: ACTIVE_COMPARATOR

Esmolol

Intervention Type: DRUG

IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min

Interventions

Lidocaine

IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h

Intervention Type: DRUG

Esmolol

IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min

Intervention Type: DRUG

Other Intervention Names

lignocaine; Brevibloc

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

olfat abd elmoniem ibrahem

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olfat Ibrahem Amin, M.D

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Faculty of Medicine

Zagazig, Elsharkia, Egypt

Countries

Egypt

Other Identifiers

5901

Identifier Type: -

Identifier Source: org_study_id