NCT04914234

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
4.2 years until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

May 31, 2021

Last Update Submit

August 20, 2025

Conditions

Keywords

atenololcontrolled hypotensionmetoprololnasal surgery

Outcome Measures

Primary Outcomes (1)

  • Mean and Standard deviation of Blood loss (ml)(mean±SD)

    Amount of blood loss at the end of surgery

    5 minutes after the end of surgery

Study Arms (2)

Group A (n=30)

ACTIVE COMPARATOR

Atenolol group

Drug: Atenolol Succinate Oral Tablet

Group M (n=30)

ACTIVE COMPARATOR

Metoprolol group

Drug: Metoprolol Succinate Oral Tablet

Interventions

Atenolol 50 mg

Also known as: Tenormin tablets
Group A (n=30)

Metoprolol 100 mg

Also known as: Seloken ZOC tablets
Group M (n=30)

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status ≤ II
  • Age from 21 to 50 years

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

AtenololMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Ahmed M Shaat, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Shaat, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 4, 2021

Study Start

August 1, 2025

Primary Completion

January 15, 2026

Study Completion

January 30, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations