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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypotension Drug-Induced

Intervention / Treatment
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* Drug: Labetalol Hydrochloride Oral Tablet
* Drug: Metoprolol Tartrate Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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controlled hypotension, endoscopic nasal surgery, labetalol, metoprolol