Clinical trial NCT04260685: Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility
Official title: Intraoperative Lidocaine Versus Esmolol Infusion for Optimizing Surgical Field Visibility During Lumbar Discectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbar Disc Herniation
Keywords: esmolol
lidocaine
surgical field
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group L (lidocaine group) (n=35): the Patient will receive IV bolus of 1.5mg/kg lidocaine 1% over ten minutes followed by continuous infusion of 1.5mg/kg/h and will be terminated 10 minutes before the end of surgery.

Group E(esmolol group) (n=35): 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 and will be terminated 10 minutes before the end of surgery.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The quality of surgical field visibility
timeFrame: from the start of surgery till the end of surgery
measure: Mean arterial blood pressure
timeFrame: from induction of anesthesia till the end of surgery
Secondary outcomes:
measure: heart rate
timeFrame: 15 minutes after the start of hypotensive agent
measure: simplified postoperative nausea and vomiting
timeFrame: for the first 24 hours postoperative
measure: surgeon satisfaction
timeFrame: "at completion of operation, an average 2 hours "
measure: The need for blood transfusion
timeFrame: "through study completion, an average of four months".
measure: the amount of blood loss
timeFrame: from the beginning of surgery till the end of surgery, an average two hours"
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Elsharkia
Study officials:
affiliation: Zagazig University
name: Olfat Ibrahem Amin, M.D
role: PRINCIPAL_INVESTIGATOR
References: