Clinical trial

Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial

Name
DTH: 21002
Description
Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries. Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. There are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding. Patients and Methods: This was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received oral atenolol, and group M, received oral metoprolol.
Trial arms
Trial start
2022-12-15
Estimated PCD
2024-08-30
Trial end
2024-08-30
Status
Recruiting
Phase
Early phase I
Treatment
Atenolol Succinate Oral Tablet
Atenolol 50 mg
Arms:
Group A (n=30)
Other names:
Tenormin tablets
Metoprolol Succinate Oral Tablet
Metoprolol 100 mg
Arms:
Group M (n=30)
Other names:
Seloken ZOC tablets
Size
60
Primary endpoint
Mean and Standard deviation of Blood loss (ml)(mean±SD)
5 minutes after the end of surgery
Eligibility criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status ≤ II * Age from 21 to 50 years Exclusion Criteria: * ASA physical status \> II * Age \< 21 years or \> 50 years * Pregnant women * Breastfeeding * Bronchial asthma * Chronic obstructive pulmonary disease * Diabetes Mellitus * 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 * Allergic fungal sinusitis * Patients on beta-blockers * Alcohol or drug abuse * Anticoagulation therapy, * Bleeding diathesis * Agents influencing autonomic nervous system * Allergy to the study drugs * Any contraindication of oral intake
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-02-20

1 organization

2 products

1 indication