PreoperativeNCT06620991
Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery
A study testing Phentolamine and Esmolol in people with Preoperative and Phentolamine, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Preoperative, Phentolamine, Intraoperative
- What is being tested?
- Phentolamine and Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 21 to 50 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
Who cannot join
- 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.
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- Previous nasal surgery.
- Patients on Non-steroidal anti-inflammatory drugs (NSAIDs).
- Patients with peripheral vascular disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University
Cairo, 11591
Eslam A Elsamahi, Master, 00201069503729, eslam.ahmed@med.asu.edu.eg
Hala G Salama, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Preoperative, Phentolamine, Intraoperative, Esmolol, Hypotensive Anesthesia, Functional Endoscopic Sinus Surgery
- Being tested
- Phentolamine, Esmolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhentolamineDrug
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
EsmololDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of surgery.
Secondary outcomes (2)
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.
Measured: Until the end of surgery
Adverse events
Adverse events will be recorded such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Elsamahi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620991
- Sponsor's protocol ID
- FMASU MD147/2023
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT06620991
- Acronym / sponsor ID
- FMASU MD147/2023
- Conditions
- Preoperative, Phentolamine, Intraoperative, Esmolol, Hypotensive Anesthesia, Functional Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phentolamine | Experimental | Drug: PhentolamineA 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 | Experimental | Drug: EsmololA 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 21 to 50 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhentolamineA 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 |
| EsmololA 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 |
Primary outcome
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.
2 secondary outcomes
Heart rate
Time frame: Until the end of surgery
Adverse events
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phentolamine and Esmolol in people with Preoperative and Phentolamine, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam A Elsamahi, Master (00201069503729, eslam.ahmed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: Until the end of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.