Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260685
• Other study ID #: 5901
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Drug:
• Lidocaine
IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h
• Esmolol
IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Zagazig	Elsharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of surgical field visibility	using the surgical field rating (SFR) scale of six points proposed by (Fromme et al 1986) : Grade 0: No bleeding - virtually bloodless field. Grade 1: Slight bleeding so no suctioning required. Grade 2: Slight bleeding so occasional suctioning required. Grade 3: Low bleeding- frequent suctioning required; bleeding threatens surgical field some seconds after suction is removed.; Grade 4: Moderate bleeding- frequent suctioning required, bleeding threatens surgical field directly after suctioning.; Grade 5: Sever bleeding so constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery hardly possible.	from the start of surgery till the end of surgery
Primary	Mean arterial blood pressure	automatically invasive measured every 3 minutes , recorded every 15 minutes till the end	from induction of anesthesia till the end of surgery
Secondary	heart rate	heart rate	15 minutes after the start of hypotensive agent
Secondary	simplified postoperative nausea and vomiting	Postoperative nausea and vomiting impact scale score	for the first 24 hours postoperative
Secondary	surgeon satisfaction	Surgeon's satisfaction score; Bad satisfaction.; moderate satisfaction.; Good satisfaction.; excellent satisfaction	"at completion of operation, an average 2 hours "
Secondary	The need for blood transfusion	The number of patients need for blood transfusion: Acute blood loss more than 1,500 ml or 30% of blood volume is in need of blood transfusion	"through study completion, an average of four months".
Secondary	the amount of blood loss	Blood loss= Hb (gdL/1) X V (mL)/Hbm (g/dL); Intraoperative blood volume loss (V)=blood in the suction container with adjustment for the used irrigating saline and the blood soaked by gauze pieces [4×4 soaked gauze piece =15 ml blood, completely soaked abdominal towel =150 ml blood].Hb= Hb concentration of suction container and Hbm=patient's mean hemoglobin concentration at the start	from the beginning of surgery till the end of surgery, an average two hours"