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Clinical Trials/NCT06670690
NCT06670690CompletedNot Applicable

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

Menoufia University1 site in 1 country120 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Perioperative Heamodynamic Effect of the drugs

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Atenolol Group

Active Comparator

patients will be premedicated with atenolol (50mg)

Intervention: Atenolol 50 MG (Drug)

propranolol Group

Active Comparator

patients will be premedicated with propranolol (10mg)

Intervention: Propranolol Pill (Drug)

Ivabradine Group

Active Comparator

patients will be premedicated with Ivabradine (5mg)

Intervention: Ivabradine (Drug)

Outcomes

Primary Outcomes

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

  • Blood loss & surgical field visibility score(Intraoperative time)
  • Anesthetic consumption(Intraoperative time)
  • Incidence of complication(Intraoperative time)
  • The need for blood transfusion(Intraoperative time)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

rabab Mohammad habeeb

Principal investigator

Menoufia University

Study Sites (1)

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