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NCT Number: NCT06620991

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

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

Location contact

Eslam A Elsamahi, Master

CONTACT

[email protected]

00201069503729

Hala G Salama, MD

SUB_INVESTIGATOR

Hatem S Abdelhamid, MD

SUB_INVESTIGATOR

Mohamed A Ibrahim, MD

SUB_INVESTIGATOR

Mohamed N Mohamed, MD

SUB_INVESTIGATOR

About this study

Functional endoscopic sinus surgery (FESS) is becoming a widely performed operation. Its introduction associated with enhanced illumination and visualization has dramatically improved surgical dissection. However major complications have been reported for FESS under general anesthesia resulting from impaired visibility due to excessive bleeding.

Esmolol is a selective β1-adrenoreceptor antagonist involved in the control of heart rate (HR), contractility, and atrioventricular conduction. Currently, the use of β-blockade for hemodynamic stability and cardiac protection is well accepted among anesthesia providers, but recently, researchers have begun to explore the perioperative use of esmolol as an anesthetic adjunct. Esmolol was found to produce desired hypotension without tachycardia and improved surgical condition by reducing operative field bleeding.

Phentolamine is well known selective α1-blocker which is used to treat hypertensive emergency by producing profound vasodilatation. The reduced blood pressure will induce response in the arterial baroreceptors leading to release of adrenal catecholamine, eventually inducing reflex tachycardia. The reflex tachycardia is less profound in the selective α1-blockers such as phentolamine. Phentolamine is a short acting drug with a context sensitive half-life of 15 minutes which makes it ideal for rapid control of blood pressure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. Mean arterial pressure

    Time frame: Until the end of surgery.

    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.

Secondary outcomes

  1. Heart rate

    Time frame: Until the end of surgery

    Heart rate 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.

  2. Adverse events

    Time frame: 24 hours postoperative

    Adverse events will be recorded such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.

Study contacts

Contact information is provided by the study sponsor or research team.

Eslam A Elsamahi, Master

CONTACT

[email protected]

00201069503729

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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