- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260685
Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility
Intraoperative Lidocaine Versus Esmolol Infusion for Optimizing Surgical Field Visibility During Lumbar Discectomy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Elsharkia
-
Zagazig, Elsharkia, Egypt, 022/055
- Faculty of medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h
Other Names:
|
Active Comparator: 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
|
IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The quality of surgical field visibility
Time Frame: from the start of surgery till the end of surgery
|
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
Time Frame: from induction of anesthesia till the end of surgery
|
automatically invasive measured every 3 minutes , recorded every 15 minutes till the end
|
from induction of anesthesia till the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate
Time Frame: 15 minutes after the start of hypotensive agent
|
heart rate
|
15 minutes after the start of hypotensive agent
|
simplified postoperative nausea and vomiting
Time Frame: for the first 24 hours postoperative
|
Postoperative nausea and vomiting impact scale score
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for the first 24 hours postoperative
|
surgeon satisfaction
Time Frame: "at completion of operation, an average 2 hours "
|
Surgeon's satisfaction score
|
"at completion of operation, an average 2 hours "
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The need for blood transfusion
Time Frame: "through study completion, an average of four months".
|
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
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"through study completion, an average of four months".
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the amount of blood loss
Time Frame: from the beginning of surgery till the end of surgery, an average two hours"
|
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
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from the beginning of surgery till the end of surgery, an average two hours"
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olfat Ibrahem Amin, M.D, Zagazig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Pathological Conditions, Anatomical
- Spinal Diseases
- Bone Diseases
- Hernia
- Intervertebral Disc Displacement
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Adrenergic beta-1 Receptor Antagonists
- Lidocaine
- Esmolol
Other Study ID Numbers
- 5901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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