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

Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries? A Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Hypotension Drug-Induced
• Intervention / Treatment: Drug: Labetalol Hydrochloride Oral Tablet; Drug: Metoprolol Tartrate Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • El-Beheira
    • Damanhūr, El-Beheira, Egypt
      • Damanhour Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M (n=30); Metoprolol group	Drug: Metoprolol Tartrate Oral Tablet; Metoprolol 100 mg; Other Names: Betaloc tablets
Active Comparator: Group L (n=30); Labetalol group	Drug: Labetalol Hydrochloride Oral Tablet; Labetalol 200 mg; Other Names: Labipress tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean and Standard deviation of Blood loss (ml)(mean±SD)	Amount of blood loss at the end of surgery	30 minutes after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)	Concentration of sevoflurane used during surgery	30 minutes after the end of surgery
Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)	Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)	30 minutes after the end of surgery
Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)	Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)	30 minutes after the end of surgery
Number of participants and Percentage of Drug-related side effects	Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV)	30 minutes after the end of surgery

Collaborators and Investigators

• Sponsor: Damanhour Teaching Hospital
• Investigators: Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: controlled hypotension; metoprolol; labetalol; endoscopic nasal surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympathomimetics; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Metoprolol; Labetalol
• Other Study ID Numbers: DTH: 22001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No