NCT05368376

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

May 5, 2022

Last Update Submit

September 25, 2023

Conditions

Hypotension Drug-Induced

Keywords

controlled hypotensionendoscopic nasal surgerylabetalolmetoprolol

Outcome Measures

Primary Outcomes (1)

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

    Amount of blood loss at the end of surgery

    30 minutes after the end of surgery

Secondary Outcomes (4)

  • Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)

    30 minutes after the end of surgery

  • Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)

    30 minutes after the end of surgery

  • Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)

    30 minutes after the end of surgery

  • Number of participants and Percentage of Drug-related side effects

    30 minutes after the end of surgery

Study Arms (2)

Group L (n=30)

ACTIVE COMPARATOR

Labetalol group

Drug: Labetalol Hydrochloride Oral Tablet

Group M (n=30)

ACTIVE COMPARATOR

Metoprolol group

Drug: Metoprolol Tartrate Oral Tablet

Interventions

Labetalol Hydrochloride Oral TabletDRUG

Labetalol 200 mg

Also known as: Labipress tablets
Group L (n=30)
Metoprolol Tartrate Oral TabletDRUG

Metoprolol 100 mg

Also known as: Betaloc 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
  • Body Mass Index (BMI) ≤ 35 kg/m2

You may not qualify if:

  • 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)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

LabetalolMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAminesPhenoxypropanolaminesPropanolaminesPropanols

Study Officials

  • Ahmed M Shaat, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

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 5, 2022

First Posted

May 10, 2022

Study Start

April 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 15, 2022

Last Updated

September 28, 2023

Record last verified: 2021-09

Locations

EG(1)