Comparison Between Atenolol,Propnalol and Ivabradine

NCT06670690 | Completed

• 1 other identifier: 9/2023ANET 13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Blood loss & surgical field visibility score

  Intraoperative time

• Anesthetic consumption

  Intraoperative time

• Incidence of complication

  Intraoperative time

• The need for blood transfusion

  Intraoperative time

Study Arms (3)

Atenolol Group

ACTIVE COMPARATOR

patients will be premedicated with atenolol (50mg)

Drug: Atenolol 50 MG

propranolol Group

ACTIVE COMPARATOR

patients will be premedicated with propranolol (10mg)

Drug: Propranolol Pill

Ivabradine Group

ACTIVE COMPARATOR

patients will be premedicated with Ivabradine (5mg)

Drug: Ivabradine

Interventions

Atenolol 50 MG DRUG

patients will be premedicated with atenolol (50mg)

Atenolol Group

Propranolol Pill DRUG

patients will be premedicated with propranolol (10mg)

propranolol Group

Ivabradine DRUG

patients will be premedicated with Ivabradine (5mg)

Ivabradine Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shepien El Kom, Menoufia Government, 32817, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Atenolol; Propranolol; Ivabradine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)