Comparison Between Atenolol,Propnalol and Ivabradine

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

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Bleeding
• Intervention / Treatment: Drug: Atenolol 50 MG; Drug: Propranolol Pill; Drug: Ivabradine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia Government
    • Shepien El Kom, Menoufia Government, Egypt, 32817
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atenolol Group; patients will be premedicated with atenolol (50mg)	Drug: Atenolol 50 MG; patients will be premedicated with atenolol (50mg)
Active Comparator: propranolol Group; patients will be premedicated with propranolol (10mg)	Drug: Propranolol Pill; patients will be premedicated with propranolol (10mg)
Active Comparator: Ivabradine Group; patients will be premedicated with Ivabradine (5mg)	Drug: Ivabradine; patients will be premedicated with Ivabradine (5mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Heamodynamic Effect of the drugs	Heart rate	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss & surgical field visibility score	quality scale proposed by Fromm and Boezaart	Intraoperative time
Anesthetic consumption	Propofol, opioid, and isoflurane consumption	Intraoperative time
Incidence of complication	The patient will be examined for bradycardia, or tachycardia hypo or hypertension, shivering, respiratory depression, dizziness, visual disturbance, nausea, and vomiting	Intraoperative time
The need for blood transfusion	The need for blood transfusion	Intraoperative time

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adrenergic Agents; Vasodilator Agents; Antihypertensive Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Atenolol; Propranolol
• Other Study ID Numbers: 9/2023ANET 13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No