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

Damanhour Teaching Hospital

Status and phase: Completed; Phase 4

Conditions: Hypotension Drug-Induced

Treatments: Drug: Labetalol Hydrochloride Oral Tablet; Drug: Metoprolol Tartrate Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05368376

DTH: 22001

Details and patient eligibility

About

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.

Enrollment: 60 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
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Group L (n=30)

Active Comparator group

Description:

Labetalol group

Treatment:

Drug: Labetalol Hydrochloride Oral Tablet

Group M (n=30)

Active Comparator group

Description:

Metoprolol group

Treatment:

Drug: Metoprolol Tartrate Oral Tablet