- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914234
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ahmed M Shaat, MD
- Phone Number: 00201223482709
- Email: ahmedshaat99@gmail.com
Study Locations
-
-
El-Beheira
-
Damanhūr, El-Beheira, Egypt
- Recruiting
- Damanhour Teaching Hospital
-
Contact:
- Ahmed M Shaat, MD
- Phone Number: 00201223482709
- Email: ahmedshaat99@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A (n=30)
Atenolol group
|
Atenolol 50 mg
Other Names:
|
|
Active Comparator: Group M (n=30)
Metoprolol group
|
Metoprolol 100 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean and Standard deviation of Blood loss (ml)(mean±SD)
Time Frame: 5 minutes after the end of surgery
|
Amount of blood loss at the end of surgery
|
5 minutes after the end of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Agents
- Anti-Arrhythmia Agents
- Adrenergic Agents
- Antihypertensive Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Metoprolol
- Atenolol
Other Study ID Numbers
- DTH: 21002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.