Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?
- Conditions
- Hypotension Drug-Induced
- Interventions
- Registration Number
- NCT05368376
- Lead Sponsor
- Damanhour Teaching Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 50 years
- Body Mass Index (BMI) ≤ 35 kg/m2
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group L (n=30) Labetalol Hydrochloride Oral Tablet Labetalol group Group M (n=30) Metoprolol Tartrate Oral Tablet Metoprolol group
- Primary Outcome Measures
Name Time Method Mean and Standard deviation of Blood loss (ml)(mean±SD) 30 minutes after the end of surgery Amount of blood loss at the end of surgery
- Secondary Outcome Measures
Name Time Method Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD) 30 minutes after the end of surgery Concentration of sevoflurane used during surgery
Mean and Standard deviation of Heart rate (beat/min.)(mean±SD) 30 minutes after the end of surgery 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)
Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD) 30 minutes after the end of surgery 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)
Number of participants and Percentage of Drug-related side effects 30 minutes after the end of surgery Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV)
Trial Locations
- Locations (1)
Damanhour Teaching Hospital
🇪🇬Damanhūr, El-Beheira, Egypt
Damanhour Teaching Hospital🇪🇬Damanhūr, El-Beheira, Egypt