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NCT Number: NCT06670690

Comparison Between Atenolol,Propnalol and Ivabradine

The aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.

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Key information

Conditions

Intraoperative Bleeding Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Shepien El Kom, Menoufia Government, 32817, Egypt

About this study

This study will investigate the effect of atenolol, propranolol, and ivabradine as oral premedication in adult patients undergoing LUMBAR SPINE SURGERY to achieve bloodless field anesthesia.

AIM OF THE WORK

  • The primary aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.
  • The secondary aims are to assess field visibility and measure the amount of blood loss in patients, and surgeon satisfaction and also to asses if there are any associated undesirable side effects of atenolol, propranolol, or Ivabradine will appear.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA physical status I and II,
  • aged from 18 to 50 years old
  • scheduled for elective lumber spine surgeries will be included in this study.

Exclusion criteria

  • Hypertension.
  • Hepatic or renal disease.
  • Diabetes Mellitus.
  • Pregnancy.
  • Coagulation disorders.
  • Anemia (Hb < 10 g/dL).
  • Ischemic heart disease
  • Drug or alcohol abuse.
  • Allergy to any of atenolol, propranolol, and ivabradine.
  • History of beta-blockers, calcium channel blockers, Tricyclic antidepressants, anticoagulant or clonidine intake.

Treatment and study plan

Atenolol 50 MG

Drug

patients will be premedicated with atenolol (50mg)

Propranolol Pill

Drug

patients will be premedicated with propranolol (10mg)

Ivabradine

Drug

patients will be premedicated with Ivabradine (5mg)

Primary outcomes

  1. Perioperative Heamodynamic Effect of the drugs

    Time frame: every 5 minutes for 15 minutes and then every 10 minutes till end of surgery, then every 15 minutes for 1hour in the recovery room

    Heart rate

Secondary outcomes

  1. Blood loss & surgical field visibility score

    Time frame: Intraoperative time

    quality scale proposed by Fromm and Boezaart

  2. Anesthetic consumption

    Time frame: Intraoperative time

    Propofol, opioid, and isoflurane consumption

  3. Incidence of complication

    Time frame: Intraoperative time

    The patient will be examined for bradycardia, or tachycardia hypo or hypertension, shivering, respiratory depression, dizziness, visual disturbance, nausea, and vomiting

  4. The need for blood transfusion

    Time frame: Intraoperative time

    The need for blood transfusion

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Comparison Between Atenolol , Propnalol and Ivabradine as a Premedication for Bloodless Field Anesthesia in Lumbar Spine Surgery ,a Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

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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