Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery

NCT06620991 | Not Yet Recruiting

• 1 other identifier: FMASU MD147/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of intra-operative phentolamine vs intraoperative esmolol for hypotensive anesthesia in functional endoscopic sinus surgery.

Conditions

Preoperative; Phentolamine; Intraoperative; Esmolol; Hypotensive Anesthesia; Functional Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• Mean arterial pressure

  Mean arterial pressure will be recorded at pre-induction, after the loading dose of the hypotensive agent, after injection of local vasoconstrictor and then every 15 minutes until the end of surgery.

  Until the end of surgery.

Secondary Outcomes (2)

• Heart rate

  Until the end of surgery

• Adverse events

  24 hours postoperative

Study Arms (2)

Phentolamine

EXPERIMENTAL

A loading dose of 1-5 mg IV bolus over 1 minute is given followed by an IV infusion of a rate of 0.1-2 mg/min according to patient desired target mean arterial pressure (MAP) 50-60 mmHg over a volume of 10ml.

Drug: Phentolamine

Esmolol

EXPERIMENTAL

A loading dose of 1 mg/kg IV infused over 1 minute is given followed by an IV infusion of 0.15-0.3 mg/kg/min according to patient desired target mean arterial pressure (MAP) 50-60 mmHg over total volume of 10ml.

Drug: Esmolol

Interventions

Phentolamine DRUG

A loading dose of 1-5 mg IV bolus over 1 minute is given followed by an IV infusion of a rate of 0.1-2 mg/min according to patient desired target mean arterial pressure (MAP) 50-60 mmHg over a volume of 10ml

Phentolamine

Esmolol DRUG

A loading dose of 1 mg/kg IV infused over 1 minute is given followed by an IV infusion of 0.15-0.3 mg/kg/min according to patient desired target mean arterial pressure (MAP) 50-60 mmHg over total volume of 10ml

Esmolol

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 21 to 50 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.

You may not qualify if:

• Patients with a medical condition that contraindicated hypotensive anesthesia, such as peripheral vascular disease, cerebrovascular stroke, carotid artery stenosis, previous myocardial infarction, ischemic heart disease, congestive heart failure, limb ischemia, uncontrolled hypertension and raised intracranial tension
• Renal disease, liver dysfunction, pregnancy.
• Patients on hypnotic or narcotic analgesic.
• History of alcohol or drug abuse.
• History of allergic reaction to any drug used in this study.
• Bleeding diathesis.
• Previous nasal surgery.
• Patients on Non-steroidal anti-inflammatory drugs (NSAIDs).
• Patients with peripheral vascular disease.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Phentolamine; esmolol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Eslam A Elsamahi, Master

CONTACT

00201069503729; eslam.ahmed@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of intensive care unit and anesthesia, Faculty of Medicine, Ain Shams University, Egypt.

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: October 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)