Comparison Between Atenolol,Propnalol and Ivabradine

Not Applicable

Completed

• Conditions: Intraoperative Bleeding
• Interventions: Drug: Atenolol 50 MG; Drug: Propranolol Pill; Drug: Ivabradine

• Registration Number: NCT06670690
• Lead Sponsor: Menoufia University

Brief Summary

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.

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 Timeline

• Study Start: 2023-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atenolol Group	Atenolol 50 MG	patients will be premedicated with atenolol (50mg)
propranolol Group	Propranolol Pill	patients will be premedicated with propranolol (10mg)
Ivabradine Group	Ivabradine	patients will be premedicated with Ivabradine (5mg)

Primary Outcome Measures

Name	Time	Method
Perioperative Heamodynamic Effect of the drugs	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 Outcome Measures

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

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shepien El Kom, Menoufia Government, Egypt