Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

NCT04260685 | Completed Phase 2

• 1 other identifier: 5901
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

esmolol; lidocaine; surgical field

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• heart rate

  15 minutes after the start of hypotensive agent

• simplified postoperative nausea and vomiting

  for the first 24 hours postoperative

• surgeon satisfaction

  "at completion of operation, an average 2 hours "

• The need for blood transfusion

  "through study completion, an average of four months".

• the amount of blood loss

  from the beginning of surgery till the end of surgery, an average two hours"

Study Arms (2)

lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

esmolol

ACTIVE COMPARATOR

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

Drug: Esmolol

Interventions

Lidocaine DRUG

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

Also known as: lignocaine

lidocaine

Esmolol DRUG

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

Also known as: Brevibloc

esmolol

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine

Zagazig, Elsharkia, 022/055, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Lidocaine; esmolol

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Olfat Ibrahem Amin, M.D

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the outcome assessor the surgeon
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 7, 2020
• Study Start: February 4, 2020
• Primary Completion: June 15, 2020
• Study Completion: June 30, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)