Clinical trial NCT05368376: Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?
Official title: Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries? A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension Drug-Induced
Keywords: controlled hypotension
endoscopic nasal surgery
labetalol
metoprolol
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Mean and Standard deviation of Blood loss (ml)(mean±SD)
timeFrame: 30 minutes after the end of surgery
Secondary outcomes:
measure: Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)
timeFrame: 30 minutes after the end of surgery
measure: Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)
timeFrame: 30 minutes after the end of surgery
measure: Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)
timeFrame: 30 minutes after the end of surgery
measure: Number of participants and Percentage of Drug-related side effects
timeFrame: 30 minutes after the end of surgery
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References: