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NCT Number: NCT04260685

Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Zagazig, Elsharkia, 022/055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Other names: lignocaine

esmolol

Drug

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

Other names: Brevibloc

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. heart rate

    Time frame: 15 minutes after the start of hypotensive agent

    heart rate

  2. simplified postoperative nausea and vomiting

    Time frame: for the first 24 hours postoperative

    Postoperative nausea and vomiting impact scale score

  3. surgeon satisfaction

    Time frame: "at completion of operation, an average 2 hours "

    Surgeon's satisfaction score

    • Bad satisfaction.
    • moderate satisfaction.
    • Good satisfaction.
    • excellent satisfaction

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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