- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04220281
Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery (prop)
Comparison of the Hypotensive Efficacy of Propofol Infusion Versus Nitroglycerin Infusion in Functional Endoscopic Sinus Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION FESS (functional endoscopic sinus surgery) is a popular minimally invasive surgical technique for management of patient with sinus pathological conditions. The aim of this sinus endoscopic surgery is to restore a normal mucociliary clearing function and drainage of sinuses. Although, it is a minimally invasive surgery but it can lead to a serious complications such as optic nerve injury, orbital cellulitis, meningitis, and rhino-oral fistulas. Bleeding is one of the obstacles that is associated with this technique that can decrease the surgical field visualization and increase the probability of complications.
One of the most important maneuvers used to minimize this bleeding is hypotensive anesthesia. The ideal hypotensive agent for anesthetist must be a familiar drug, easy to use, rapid onset and offset and with minimal side effects. Nitroglycerin infusion is a frequently used drug to produce controlled hypotension, as it is cheap and easy to use drug rapid onset and offset time. But a common side effect is reflex tachycardia and venous congestion which may also obscures the surgical filed and decreases surgeon satisfaction.
Total intravenous anesthesia (TIVA) using propofol and remifentanil is a common procedure used in western countries. In Egypt remifentanil is not freely available. So this study will be designed to use inhalational anesthesia and use propofol infusion as a hypotensive agent and to determine whether controlled hypotension, surgeon's satisfaction and better operative filed can be achieved when compared to nitroglycerine infusion.
- AIM OF THE WORK The aim of the study is to identify the efficacy of propofol infusion as a hypotensive agent in comparison with nitroglycerin infusion during FESS.
Study Design
A total of 40 adult patients undergoing FESS procedure for sinusitis. Written informed consent will be obtained from all patients before randomization. Patients will be divided equally into two groups the first 20 patients will be assigned to propofol group (Prop group) and the other group to nitroglycerin group (NTG group). Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study. The patients, the ENT surgeon, and the anesthetist collecting data all were blind to the groups. The anesthetist performing the general anesthesia was not blinded to the drug given but he was not one of the study participants.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
EL Abassia
-
Cairo, EL Abassia, Egypt, 11591
- Ain Shams University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients ASA I and II diagnosed for chronic sinusitis
- Age range between 18-60 years, undergoing elective FESS without septoplasty under general anesthesia.
Exclusion Criteria:
- included any patient with bleeding disorder, on anticoagulant therapy
- renal, hepatic or cardiac dysfunction
- history of cerebrovascular stroke
- peripheral vascular diseases
- allergic to any of the study drugs
- hypertension
- morbid obesity and
- recurrent endoscopic sinus surgeries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: propofol group
propofol group will receive propofol infusion
|
propofol infusion during surgery
Other Names:
|
Active Comparator: nitroglycerin group
will receive nitroglycerin infusion
|
nitroglycerin infusion during surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
efficacy of propofol infusion as a hypotensive agent in comparison with nitroglycerin infusion in FESS surgeries under general anesthesia
Time Frame: the study data collected during the time of surgery ranging from 1-2 hours
|
measuring MAP every 5 min all over the time of surgery comparing the two study groups (propofol infusion versus nitroglycerin infusion)
|
the study data collected during the time of surgery ranging from 1-2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measuring the pulse rate
Time Frame: the study data collected during the time of surgery ranging from 1-2 hours
|
comparing the pulse rate (beat/min) every 5 min all over the time of surgery comparing the two study groups (propofol infusion versus nitroglycerin infusion)
|
the study data collected during the time of surgery ranging from 1-2 hours
|
visibility of the surgical field by using the Average Category Scale
Time Frame: done by the surgeon immediately after the surgery
|
evaluation of the visibility of the operative field during surgery by using the average category scale.
minimum is grade 0 and maximum grade 5. the less the grade the better the visibility of the surgical field.
|
done by the surgeon immediately after the surgery
|
amount of blood loss
Time Frame: done by the anesthetist every 1 hour during the surgery
|
measuring the amount of blood lost during the surgery by ml/hr
|
done by the anesthetist every 1 hour during the surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rasha G Abusinna, MD, Ain Shams University Hospitals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RGAbusinna
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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