Endoscopic Sinus SurgeryNCT04078659
Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery
A study testing Propofol infusion, Magnesium Sulfate infusion and Lidocaine in people with Endoscopic Sinus Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
Endoscopic Sinus surgery usually associated by bleeding, despite using of local vasopressor injection, head up position- controlled hypotension is generally used for control of this purpose. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Endoscopic Sinus Surgery
- What is being tested?
- Propofol infusion, Magnesium Sulfate infusion and Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2019to Feb 2020
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists Physical Classes I or II
Who cannot join
- Patients refusal
- Patients with hypersensitivity for any drug used in the study including magnesium, propofol or isoflurane
- Patients receiving magnesium sulfate supplementation
- Patients receiving drugs known to have significant interaction.
- Patients with ischemic heart disease
- Patients with heart defects
Show all 9Show fewer
- Patients with significant heart failure
- Patients with increased intracranial pressure.
- Patients with systemic hypertension
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Nabil A Abd El-Mageed
Al Mansurah, DK, 050
Nabil A Abd El-Mageed, MD, 00201001538648 ext. 00201001538648, nabil-abdelraouf@yahoo.com
Hazem E Meawad, MD, 00201121516041, hazemmoawad@yahoo.com
About this study
Official title: Controlled Hypotension During Endoscopic Sinus Surgery: A Comparison of Propofol and Magnesium Sulfate
Endoscopic Sinus surgery usually associated by bleeding, despite using of local vasopressor injection, head up position- controlled hypotension is generally used for control of this purpose.
Propofol has been reported as a good agent for controlled hypotension by decreasing systemic vascular resistance secondary to arterial and venous vasodilation and a decrease in myocardial contractility with a dose-dependent property.
Read more
Magnesium Sulfate also has been reported as an agent of hypotensive anaesthesia by inhibition of the release of norepinephrine by blocking N-type calcium channel at the nerve ending beside acting as a vasodilator.
The well known pharmacodynamic effects of the intravenous infusion of propofol or Magnesium Sulfate may prove the advantage of this group in controlling intraoperative blood pressure thus reducing surgical field bleeding.
Read the detailed description
The aim of the work to compare the efficacy of propofol and magnesium sulfate to control blood pressure during endoscopic sinus surgery and the resultant effects on the quality of the surgical field including bleeding and visibility.
- Conditions
- Endoscopic Sinus Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol infusionDrug
Following induction of anaesthesia, propofol infusion will be started 75 mcg/kg/min for the first 10-15 minutes, then a maintenance infusion of propofol (50 mcg/kg /min)
Magnesium Sulfate infusionDrug
Before induction of anaesthesia, Magnesium Sulfate infusion will be started at 40 mg/kg in 100 ml saline over 10 minutes as the loading dose then Magnesium sulfate infusion 10-15 mg/kg/hr started immediately after induction of anaesthesia
LidocaineDrug
Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
FentanylDrug
Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
PropofolDrug
Patients will receive propofol in a dose of 1-2 mg /kg
AtracuriumDrug
Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation
Mechanical VentilationProcedure or surgery
Patients lungs will be ventilated using the volume controlled mechanically ventilated with 40% oxygen in the air with positive end-expiratory pressure (PEEP) of 5 cmH2O, tidal volume 500 ml and Respiratory Rate of 12 per minute
| Study group | Role | What they receive |
|---|---|---|
| Propofol infusion | Experimental | Patients received intravenous Propofol infusion Receives: Drug: Propofol infusion; Drug: Lidocaine; Drug: Fentanyl; Drug: Propofol; Drug: Atracurium; Procedure: Mechanical Ventilation |
| Magnesium Sulfate infusion | Experimental | Patients received intravenous Magnesium Sulfate infusion Receives: Drug: Magnesium Sulfate infusion; Drug: Lidocaine; Drug: Fentanyl; Drug: Propofol; Drug: Atracurium; Procedure: Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure (MAP)
automatically non invasive measured every 3 minutes , recorded every 15 minutes till the end and 15 minutes after extubation the end and 15 minutes after extubation
Measured: 15 minutes after the induction of the hypotensive agent
Secondary outcomes (9)
The blood loss
The blood loss would be calculated using the following formula Blood Loss = Blood Volume. In )Hct 1 / Hct2)
Measured: at the end of the surgery
The number of patients will need nitroglycerine and dose
The number of patients will need nitroglycerine
Measured: at the end of the surgery
Use of Ephedrine
The number of patients will need ephedrine
Measured: at the end of the surgery
Need for blood transfusion
The number of patient need for blood transfusion
Measured: at the end of the surgery
Postoperative Ramsey sedation
patient awake, anxious, agitated or restless 2 patient awake -1co operative, oriented and tranquil 3 patient drowsy with respond to command 4 patient asleep brisk response to glabella tap or loud auditory sound 5 patient asleep with sluggish response to stimulus 6 patient hasno response to nail bed pressure or othernoxious stimuli
Measured: for the first hour postoperative
Simplified post operative nausea and vomiting score
using impact scale score evaluation
Measured: for the first 24 hour postoperative
Recovery time
time needed to reach modified aldrete score> or=9)
Measured: one hour after extubation
Heart rate (HR)
Measured: 15 minutes after the start of the hypotensive agent
surgical field assessment
By the surgeon interms of bleeding and visibility using a 6-option Liker-scale scale adapted from Fromme el al. (26): 0 = no bleeding; 1 = minor bleeding, but no aspiration required; 2 = minor bleeding, aspiration required; 3 = minor bleeding, frequent aspiration required; 4 = moderate bleeding, visible� only with aspiration; 5 = severe bleeding, continuous aspiration required
Measured: 2 hours intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazem E Moawed, Study director, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078659
- Sponsor's protocol ID
- MS ∕18.08.247
- Status last verified
- Sep 2019
- First submitted
- 2 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Hypotension During Endoscopic Sinus Surgery: A Comparison of Propofol and Magnesium Sulfate
- ClinicalTrials.gov ID
- NCT04078659
- Acronym / sponsor ID
- MS ∕18.08.247
- Conditions
- Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 6 Sep 2019 (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.
Endoscopic Sinus surgery usually associated by bleeding, despite using of local vasopressor injection, head up position- controlled hypotension is generally used for control of this purpose.
Propofol has been reported as a good agent for controlled hypotension by decreasing systemic vascular resistance secondary to arterial and venous vasodilation and a decrease in myocardial contractility with a dose-dependent property.
Magnesium Sulfate also has been reported as an agent of hypotensive anaesthesia by inhibition of the release of norepinephrine by blocking N-type calcium channel at the nerve ending beside acting as a vasodilator.
The well known pharmacodynamic effects of the intravenous infusion of propofol or Magnesium Sulfate may prove the advantage of this group in controlling intraoperative blood pressure thus reducing surgical field bleeding.
Detailed description
The aim of the work to compare the efficacy of propofol and magnesium sulfate to control blood pressure during endoscopic sinus surgery and the resultant effects on the quality of the surgical field including bleeding and visibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol infusion | Experimental | Drug: Propofol infusion, Drug: Lidocaine, Drug: Fentanyl, Drug: Propofol, Drug: Atracurium, Procedure: Mechanical VentilationPatients received intravenous Propofol infusion |
| Magnesium Sulfate infusion | Experimental | Drug: Magnesium Sulfate infusion, Drug: Lidocaine, Drug: Fentanyl, Drug: Propofol, Drug: Atracurium, Procedure: Mechanical VentilationPatients received intravenous Magnesium Sulfate infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists Physical Classes I or II
Key exclusion criteria (9 listed)
- Patients refusal
- Patients with hypersensitivity for any drug used in the study including magnesium, propofol or isoflurane
- Patients receiving magnesium sulfate supplementation
- Patients receiving drugs known to have significant interaction.
- Patients with ischemic heart disease
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 |
|---|---|---|
| Propofol infusionFollowing induction of anaesthesia, propofol infusion will be started 75 mcg/kg/min for the first 10-15 minutes, then a maintenance infusion of propofol (50 mcg/kg /min) | Drug | Propofol infusion |
| Magnesium Sulfate infusionBefore induction of anaesthesia, Magnesium Sulfate infusion will be started at 40 mg/kg in 100 ml saline over 10 minutes as the loading dose then Magnesium sulfate infusion 10-15 mg/kg/hr started immediately after induction of anaesthesia | Drug | Magnesium Sulfate infusion |
| LidocainePatients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia | Drug | Magnesium Sulfate infusion, Propofol infusion |
| FentanylPatients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia | Drug | Magnesium Sulfate infusion, Propofol infusion |
| PropofolPatients will receive propofol in a dose of 1-2 mg /kg | Drug | Magnesium Sulfate infusion, Propofol infusion |
| AtracuriumPatients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation | Drug | Magnesium Sulfate infusion, Propofol infusion |
| Mechanical VentilationPatients lungs will be ventilated using the volume controlled mechanically ventilated with 40% oxygen in the air with positive end-expiratory pressure (PEEP) of 5 cmH2O, tidal volume 500 ml and Respiratory Rate of 12 per minute | Procedure or surgery | Magnesium Sulfate infusion, Propofol infusion |
Primary outcome
Mean arterial blood pressure (MAP)
Time frame: 15 minutes after the induction of the hypotensive agent
automatically non invasive measured every 3 minutes , recorded every 15 minutes till the end and 15 minutes after extubation the end and 15 minutes after extubation
9 secondary outcomes
The blood loss
Time frame: at the end of the surgery
The number of patients will need nitroglycerine and dose
Time frame: at the end of the surgery
Use of Ephedrine
Time frame: at the end of the surgery
Need for blood transfusion
Time frame: at the end of the surgery
Postoperative Ramsey sedation
Time frame: for the first hour postoperative
Simplified post operative nausea and vomiting score
Time frame: for the first 24 hour postoperative
Recovery time
Time frame: one hour after extubation
Heart rate (HR)
Time frame: 15 minutes after the start of the hypotensive agent
surgical field assessment
Time frame: 2 hours intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Yes
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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.
Hazem E Moawed study director
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol infusion, Magnesium Sulfate infusion and Lidocaine in people with Endoscopic Sinus Surgery, run by Mansoura 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 1 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 6 Sep 2019. 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 Nabil A Abd El-Mageed, MD (00201001538648 ext. 00201121516041, nabil-abdelraouf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (MAP) (time frame: 15 minutes after the induction of the hypotensive agent). 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 6 Sep 2019.