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Clinical Trials/NCT04914234
NCT04914234RecruitingPhase 4

Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial

Damanhour Teaching Hospital1 site in 1 country60 target enrollmentStarted: August 1, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Mean and Standard deviation of Blood loss (ml)(mean±SD)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group A (n=30)

Active Comparator

Atenolol group

Intervention: Atenolol Succinate Oral Tablet (Drug)

Group M (n=30)

Active Comparator

Metoprolol group

Intervention: Metoprolol Succinate Oral Tablet (Drug)

Outcomes

Primary Outcomes

Mean and Standard deviation of Blood loss (ml)(mean±SD)

Time Frame: 5 minutes after the end of surgery

Amount of blood loss at the end of surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Damanhour Teaching Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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