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Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries

Primary Purpose

Hypotension Drug-Induced

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Atenolol Succinate Oral Tablet
Metoprolol Succinate Oral Tablet
Sponsored by
Damanhour Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension Drug-Induced focused on measuring atenolol, controlled hypotension, metoprolol, nasal surgery

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Damanhour Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A (n=30)

Group M (n=30)

Arm Description

Atenolol group

Metoprolol group

Outcomes

Primary Outcome Measures

Mean and Standard deviation of Blood loss (ml)(mean±SD)
Amount of blood loss at the end of surgery

Secondary Outcome Measures

Full Information

First Posted
May 31, 2021
Last Updated
June 27, 2023
Sponsor
Damanhour Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04914234
Brief Title
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries
Official Title
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension Drug-Induced
Keywords
atenolol, controlled hypotension, metoprolol, nasal surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (n=30)
Arm Type
Active Comparator
Arm Description
Atenolol group
Arm Title
Group M (n=30)
Arm Type
Active Comparator
Arm Description
Metoprolol group
Intervention Type
Drug
Intervention Name(s)
Atenolol Succinate Oral Tablet
Other Intervention Name(s)
Tenormin tablets
Intervention Description
Atenolol 50 mg
Intervention Type
Drug
Intervention Name(s)
Metoprolol Succinate Oral Tablet
Other Intervention Name(s)
Seloken ZOC tablets
Intervention Description
Metoprolol 100 mg
Primary Outcome Measure Information:
Title
Mean and Standard deviation of Blood loss (ml)(mean±SD)
Description
Amount of blood loss at the end of surgery
Time Frame
5 minutes after the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Shaat, MD
Phone
00201223482709
Email
ahmedshaat99@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damanhour Teaching Hospital
City
Damanhūr
State/Province
El-Beheira
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Phone
00201223482709
Email
ahmedshaat99@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries

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