Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries

Phase 4

Recruiting

• Conditions: Hypotension Drug-Induced
• Interventions: Drug: Atenolol Succinate Oral Tablet; Drug: Metoprolol Succinate Oral Tablet

• Registration Number: NCT04914234
• Lead Sponsor: Damanhour Teaching Hospital

Brief Summary

Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries.

Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. There are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding.

Patients and Methods: This was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received oral atenolol, and group M, received oral metoprolol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-04
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status ≤ II
• Age from 21 to 50 years

Exclusion Criteria

• ASA physical status > II
• Age < 21 years or > 50 years
• Pregnant women
• Breastfeeding
• Bronchial asthma
• Chronic obstructive pulmonary disease
• Diabetes Mellitus
• Hypertension
• Ischemic heart disease
• Rheumatic heart disease
• Heart failure
• Heart block
• Sick sinus syndrome
• Sinus bradycardia
• Chronic hypotension
• Anemia (Hb < 10 g/dl)
• Renal or hepatic dysfunction
• Central nervous system disease
• Allergic fungal sinusitis
• Patients on beta-blockers
• Alcohol or drug abuse
• Anticoagulation therapy,
• Bleeding diathesis
• Agents influencing autonomic nervous system
• Allergy to the study drugs
• Any contraindication of oral intake

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (n=30)	Atenolol Succinate Oral Tablet	Atenolol group
Group M (n=30)	Metoprolol Succinate Oral Tablet	Metoprolol group

Primary Outcome Measures

Name	Time	Method
Mean and Standard deviation of Blood loss (ml)(mean±SD)	5 minutes after the end of surgery	Amount of blood loss at the end of surgery

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt