Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?

NCT ID: NCT05368376

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-10-15

Brief Summary

Background: Mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. There are several pharmacological techniques for the appropriate control of intraoperative bleeding.

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

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

Conditions

Hypotension Drug-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group L (n=30)

Labetalol group

Group Type: ACTIVE_COMPARATOR

Labetalol Hydrochloride Oral Tablet

Intervention Type: DRUG

Labetalol 200 mg

Group M (n=30)

Metoprolol group

Group Type: ACTIVE_COMPARATOR

Metoprolol Tartrate Oral Tablet

Intervention Type: DRUG

Metoprolol 100 mg

Interventions

Labetalol Hydrochloride Oral Tablet

Labetalol 200 mg

Intervention Type: DRUG

Metoprolol Tartrate Oral Tablet

Metoprolol 100 mg

Intervention Type: DRUG

Other Intervention Names

Labipress tablets; Betaloc tablets

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status ≤ II
• Age from 21 to 50 years
• Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion Criteria

• ASA physical status > II
• Age < 21 years or > 50 years
• Pregnant women
• Breastfeeding
• Bronchial asthma
• Chronic obstructive pulmonary disease
• 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
• Bleeding diathesis
• Diabetes Mellitus
• Allergic fungal sinusitis
• Patients on beta-blockers, tricyclic antidepressants, alcohol or drug abuse, anticoagulation therapy, agents influencing the autonomic nervous system
• Patients using pacemakers
• Allergy to the study drugs
• Any contraindication of oral intake

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Locations

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Countries

Egypt

Other Identifiers

DTH: 22001

Identifier Type: -

Identifier Source: org_study_id