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Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine
Esmolol
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lumbar Disc Herniation focused on measuring esmolol, lidocaine, surgical field

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

lidocaine

esmolol

Arm 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

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

Outcomes

Primary Outcome Measures

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.
Mean arterial blood pressure
automatically invasive measured every 3 minutes , recorded every 15 minutes till the end

Secondary Outcome Measures

heart rate
heart rate
simplified postoperative nausea and vomiting
Postoperative nausea and vomiting impact scale score
surgeon satisfaction
Surgeon's satisfaction score Bad satisfaction. moderate satisfaction. Good satisfaction. excellent satisfaction
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
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

Full Information

First Posted
January 21, 2020
Last Updated
June 30, 2020
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04260685
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
esmolol, lidocaine, surgical field

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderOutcomes Assessor
Masking Description
the outcome assessor the surgeon
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lidocaine
Arm Type
Active Comparator
Arm 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
Arm Title
esmolol
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
lignocaine
Intervention Description
IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Esmolol
Other Intervention Name(s)
Brevibloc
Intervention Description
IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min
Primary Outcome Measure Information:
Title
The quality of surgical field visibility
Description
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.
Time Frame
from the start of surgery till the end of surgery
Title
Mean arterial blood pressure
Description
automatically invasive measured every 3 minutes , recorded every 15 minutes till the end
Time Frame
from induction of anesthesia till the end of surgery
Secondary Outcome Measure Information:
Title
heart rate
Description
heart rate
Time Frame
15 minutes after the start of hypotensive agent
Title
simplified postoperative nausea and vomiting
Description
Postoperative nausea and vomiting impact scale score
Time Frame
for the first 24 hours postoperative
Title
surgeon satisfaction
Description
Surgeon's satisfaction score Bad satisfaction. moderate satisfaction. Good satisfaction. excellent satisfaction
Time Frame
"at completion of operation, an average 2 hours "
Title
The need for blood transfusion
Description
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
Time Frame
"through study completion, an average of four months".
Title
the amount of blood loss
Description
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
Time Frame
from the beginning of surgery till the end of surgery, an average two hours"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olfat Ibrahem Amin, M.D
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Zagazig
State/Province
Elsharkia
ZIP/Postal Code
022/055
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

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