Hypotensive AnesthesiaPhase 1/2propNCT04220281
Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery
A Phase 1/2 study testing Propofol and Nitroglycerin in people with Hypotensive Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotensive Anesthesia
- What is being tested?
- Propofol and Nitroglycerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 12 Feb 2020
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients ASA I and II diagnosed for chronic sinusitis
- Age range between 18-60 years, undergoing elective FESS without septoplasty under general anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Hypotensive Efficacy of Propofol Infusion Versus Nitroglycerin Infusion in Functional Endoscopic Sinus Surgery
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.
Read the 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.
- Conditions
- Hypotensive Anesthesia
- Being tested
- Propofol, Nitroglycerin
- Keywords
- propofol, nitroglycerin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called prop
propofol infusion during surgery
NitroglycerinDrug
Also called NTG
nitroglycerin infusion during surgery
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Active comparator | propofol group will receive propofol infusion Receives: Drug: Propofol |
| nitroglycerin group | Active comparator | will receive nitroglycerin infusion Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: the study data collected during the time of surgery ranging from 1-2 hours
Secondary outcomes (3)
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)
Measured: 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
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.
Measured: done by the surgeon immediately after the surgery
amount of blood loss
measuring the amount of blood lost during the surgery by ml/hr
Measured: done by the anesthetist every 1 hour during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Dec 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Why it stopped: the number of patients needed for the study have been collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotensive AnesthesiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Gamal Abusinna, Ain Shams University
- Investigators
- Rasha G Abusinna, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220281
- Sponsor's protocol ID
- RGAbusinna
- Acronym
- prop
- Status last verified
- Feb 2020
- First submitted
- 4 Jan 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Hypotensive Efficacy of Propofol Infusion Versus Nitroglycerin Infusion in Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT04220281
- Acronym / sponsor ID
- prop / RGAbusinna
- Conditions
- Hypotensive Anesthesia
- Keywords
- propofol, nitroglycerin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the number of patients needed for the study have been collected
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 7 Jan 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Active comparator | Drug: Propofolpropofol group will receive propofol infusion |
| nitroglycerin group | Active comparator | Drug: Nitroglycerinwill receive nitroglycerin infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients ASA I and II diagnosed for chronic sinusitis
- Age range between 18-60 years, undergoing elective FESS without septoplasty under general anesthesia.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| PropofolAlso: proppropofol infusion during surgery | Drug | propofol group |
| NitroglycerinAlso: NTGnitroglycerin infusion during surgery | Drug | nitroglycerin group |
Primary outcome
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)
3 secondary outcomes
measuring the pulse rate
Time frame: 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
amount of blood loss
Time frame: done by the anesthetist every 1 hour during the surgery
Results and safety
The study was stopped early (reason given: the number of patients needed for the study have been collected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Rasha G Abusinna, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Propofol and Nitroglycerin in people with Hypotensive Anesthesia, 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Feb 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the number of patients needed for the study have been collected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 17 Feb 2020.