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Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?

Primary Purpose

Hypotension Drug-Induced

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Labetalol Hydrochloride Oral Tablet
Metoprolol Tartrate 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 controlled hypotension, endoscopic nasal surgery, labetalol, metoprolol

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
  • Patients on beta-blockers
  • Patients on calcium channel 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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group L (n=30)

Group M (n=30)

Arm Description

Labetalol 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

Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)
Concentration of sevoflurane used during surgery
Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)
Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)
Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)
Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)
Number of participants and Percentage of Drug-related side effects
Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV)

Full Information

First Posted
May 5, 2022
Last Updated
September 25, 2023
Sponsor
Damanhour Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05368376
Brief Title
Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?
Official Title
Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries? A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

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
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group L (n=30)
Arm Type
Active Comparator
Arm Description
Labetalol group
Arm Title
Group M (n=30)
Arm Type
Active Comparator
Arm Description
Metoprolol group
Intervention Type
Drug
Intervention Name(s)
Labetalol Hydrochloride Oral Tablet
Other Intervention Name(s)
Labipress tablets
Intervention Description
Labetalol 200 mg
Intervention Type
Drug
Intervention Name(s)
Metoprolol Tartrate Oral Tablet
Other Intervention Name(s)
Betaloc 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
30 minutes after the end of surgery
Secondary Outcome Measure Information:
Title
Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)
Description
Concentration of sevoflurane used during surgery
Time Frame
30 minutes after the end of surgery
Title
Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)
Description
Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)
Time Frame
30 minutes after the end of surgery
Title
Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)
Description
Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)
Time Frame
30 minutes after the end of surgery
Title
Number of participants and Percentage of Drug-related side effects
Description
Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV)
Time Frame
30 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 Body Mass Index (BMI) ≤ 35 kg/m2 Exclusion Criteria: 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) Renal or hepatic dysfunction Central nervous system disease Bleeding diathesis Diabetes Mellitus Allergic fungal sinusitis Patients on beta-blockers, tricyclic antidepressants, alcohol or drug abuse, anticoagulation therapy, agents influencing the autonomic nervous system Patients using pacemakers Allergy to the study drugs Any contraindication of oral intake
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

12. IPD Sharing Statement

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Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?

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