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Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery (prop)

Primary Purpose

Hypotensive Anesthesia

Status
Terminated
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Propofol
Nitroglycerin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypotensive Anesthesia focused on measuring propofol, nitroglycerin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propofol group

nitroglycerin group

Arm Description

propofol group will receive propofol infusion

will receive nitroglycerin infusion

Outcomes

Primary Outcome Measures

efficacy of propofol infusion as a hypotensive agent in comparison with nitroglycerin infusion in FESS surgeries under general anesthesia
measuring MAP every 5 min all over the time of surgery comparing the two study groups (propofol infusion versus nitroglycerin infusion)

Secondary Outcome Measures

measuring the pulse rate
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)
visibility of the surgical field by using the Average Category Scale
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.
amount of blood loss
measuring the amount of blood lost during the surgery by ml/hr

Full Information

First Posted
January 4, 2020
Last Updated
February 12, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04220281
Brief Title
Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery
Acronym
prop
Official Title
Comparison of the Hypotensive Efficacy of Propofol Infusion Versus Nitroglycerin Infusion in Functional Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
the number of patients needed for the study have been collected
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background and Objectives: FESS is a common minimally invasive surgery that requires a clear field to be performed well. Hypotensive anesthesia is one of the most common maneuvers performed to help in keeping the field clear. An ideal drug for hypotensive anesthesia should be cheap and familial to the anesthesiologist. So being familial with propofol and by using its cardio-depressant action the idea of the research was developed and comparing it with nitroglycerin (a hypotensive agent in our protocol). Methods: The patients agreed to participate in the research were classified into two groups for comparison. Propofol group; received propofol infusion all over the procedure, and nitroglycerin group; received nitroglycerin infusion all over the procedure. Duration of surgery, visibility of surgical field and amount of blood loss were recorded. Pulse/min and MAP were recorded at baseline and every 5 min. Results: The mean duration of surgery was longer in the NTG to propofol group. There was high statistical significance in the average blood loss in the propofol group compared to NTG group. The visibility of the operative field also was significant in the propofol group as compared to NTG group. The mean heart rate in the NTG group is higher than the mean heart rate in the propofol group. The MAP in both groups is within a close range. Conclusion: Propofol and NTG can produce a safe and effective controlled hypotension during FESS. Whereas, propofol has; a better surgical field visibility, less surgical bleeding and less tachycardia during FESS.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotensive Anesthesia
Keywords
propofol, nitroglycerin

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
propofol group
Arm Type
Active Comparator
Arm Description
propofol group will receive propofol infusion
Arm Title
nitroglycerin group
Arm Type
Active Comparator
Arm Description
will receive nitroglycerin infusion
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
prop
Intervention Description
propofol infusion during surgery
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Other Intervention Name(s)
NTG
Intervention Description
nitroglycerin infusion during surgery
Primary Outcome Measure Information:
Title
efficacy of propofol infusion as a hypotensive agent in comparison with nitroglycerin infusion in FESS surgeries under general anesthesia
Description
measuring MAP every 5 min all over the time of surgery comparing the two study groups (propofol infusion versus nitroglycerin infusion)
Time Frame
the study data collected during the time of surgery ranging from 1-2 hours
Secondary Outcome Measure Information:
Title
measuring the pulse rate
Description
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)
Time Frame
the study data collected during the time of surgery ranging from 1-2 hours
Title
visibility of the surgical field by using the Average Category Scale
Description
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.
Time Frame
done by the surgeon immediately after the surgery
Title
amount of blood loss
Description
measuring the amount of blood lost during the surgery by ml/hr
Time Frame
done by the anesthetist every 1 hour during the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasha G Abusinna, MD
Organizational Affiliation
Ain Shams University hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
State/Province
EL Abassia
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

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Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery

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