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

Hypotension Drug-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914234
• Other study ID #: DTH: 21002
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2023
• Source: Damanhour Teaching Hospital
• Contact: Ahmed M Shaat, MD
• Phone: 00201223482709
• Email: ahmedshaat99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension Drug-Induced

Intervention

Drug:
• Atenolol Succinate Oral Tablet
Atenolol 50 mg
• Metoprolol Succinate Oral Tablet
Metoprolol 100 mg

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean and Standard deviation of Blood loss (ml)(mean±SD)	Amount of blood loss at the end of surgery	5 minutes after the end of surgery