- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078659
Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery
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.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nabil A Abd El-Mageed, MD
- Phone Number: 00201121516041 00201001538648
- Email: nabil-abdelraouf@yahoo.com
Study Contact Backup
- Name: Hazem E Moawed, MD
- Phone Number: 00201121516041 00201121516041
- Email: hazemmoawad@yahoo.com
Study Locations
-
-
DK
-
Mansoura, DK, Egypt, 050
- Nabil A Abd El-Mageed
-
Contact:
- Nabil A Abd El-Mageed, MD
- Phone Number: 00201001538648 00201001538648
- Email: nabil-abdelraouf@yahoo.com
-
Contact:
- Hazem E Meawad, MD
- Phone Number: 00201121516041
- Email: hazemmoawad@yahoo.com
-
Sub-Investigator:
- Maha A Abo-Zeid, MD
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Sub-Investigator:
- Mohamed E Mohamed, M.Sec
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists Physical Classes I or II
Exclusion Criteria:
- 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
- Patients with significant heart failure
- Patients with increased intracranial pressure.
- Patients with systemic hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Propofol infusion
Patients received intravenous Propofol infusion
|
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)
Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
Patients will receive propofol in a dose of 1-2 mg /kg
Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation
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
|
Experimental: Magnesium Sulfate infusion
Patients received intravenous Magnesium Sulfate infusion
|
Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
Patients will receive propofol in a dose of 1-2 mg /kg
Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15 minutes after the induction of the hypotensive agent
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The blood loss
Time Frame: at the end of the surgery
|
The blood loss would be calculated using the following formula Blood Loss = Blood Volume.
In )Hct 1 / Hct2)
|
at the end of the surgery
|
The number of patients will need nitroglycerine and dose
Time Frame: at the end of the surgery
|
The number of patients will need nitroglycerine
|
at the end of the surgery
|
Use of Ephedrine
Time Frame: at the end of the surgery
|
The number of patients will need ephedrine
|
at the end of the surgery
|
Need for blood transfusion
Time Frame: at the end of the surgery
|
The number of patient need for blood transfusion
|
at the end of the surgery
|
Postoperative Ramsey sedation
Time Frame: for the first hour postoperative
|
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
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for the first hour postoperative
|
Simplified post operative nausea and vomiting score
Time Frame: for the first 24 hour postoperative
|
using impact scale score evaluation
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for the first 24 hour postoperative
|
Recovery time
Time Frame: one hour after extubation
|
time needed to reach modified aldrete score> or=9)
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one hour after extubation
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Heart rate (HR)
Time Frame: 15 minutes after the start of the hypotensive agent
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15 minutes after the start of the hypotensive agent
|
|
surgical field assessment
Time Frame: 2 hours intraoperative
|
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
|
2 hours intraoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hazem E Moawed, assistant professor of Anesthesia and Surgical Intensive Care
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anticonvulsants
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Neuromuscular Agents
- Tocolytic Agents
- Nicotinic Antagonists
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Fentanyl
- Propofol
- Lidocaine
- Magnesium Sulfate
- Atracurium
Other Study ID Numbers
- MS ∕18.08.247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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