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

D

Damanhour Teaching Hospital

Status and phase

Enrolling
Phase 4

Conditions

Hypotension Drug-Induced

Treatments

Drug: Atenolol Succinate Oral Tablet
Drug: Metoprolol Succinate Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04914234
DTH: 21002

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Group A (n=30)
Active Comparator group
Description:
Atenolol group
Treatment:
Drug: Atenolol Succinate Oral Tablet
Group M (n=30)
Active Comparator group
Description:
Metoprolol group
Treatment:
Drug: Metoprolol Succinate Oral Tablet

Trial contacts and locations

1

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Central trial contact

Ahmed M Shaat, MD

Data sourced from clinicaltrials.gov

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