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

Hypotension Drug-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368376
• Other study ID #: DTH: 22001
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: September 2021
• Source: Damanhour Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 15, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension Drug-Induced

Intervention

Drug:
• Labetalol Hydrochloride Oral Tablet
Labetalol 200 mg
• Metoprolol Tartrate Oral Tablet
Metoprolol 100 mg

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)	Concentration of sevoflurane used during surgery	30 minutes after the end of surgery
Secondary	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
Secondary	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
Secondary	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