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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 21 to 50 years.

Both sexes.

American Society of Anesthesiologists (ASA) physical status I-II.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PhentolamineExperimental treatment 1 intervention
Group B: EsmololExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Until the end of surgery.

Secondary outcomes

1

Heart rate

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.

Time frame
Until the end of surgery
2

Adverse events

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

Time frame
24 hours postoperative

Other outcomes

Sponsors and contacts

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