Clinical trial NCT04078659: Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery
Official title: Controlled Hypotension During Endoscopic Sinus Surgery: A Comparison of Propofol and Magnesium Sulfate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Sinus Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean arterial blood pressure (MAP)
timeFrame: 15 minutes after the induction of the hypotensive agent
Secondary outcomes:
measure: The blood loss
timeFrame: at the end of the surgery
measure: The number of patients will need nitroglycerine and dose
timeFrame: at the end of the surgery
measure: Use of Ephedrine
timeFrame: at the end of the surgery
measure: Need for blood transfusion
timeFrame: at the end of the surgery
measure: Postoperative Ramsey sedation
timeFrame: for the first hour postoperative
measure: Simplified post operative nausea and vomiting score
timeFrame: for the first 24 hour postoperative
measure: Recovery time
timeFrame: one hour after extubation
measure: Heart rate (HR)
timeFrame: 15 minutes after the start of the hypotensive agent
measure: surgical field assessment
timeFrame: 2 hours intraoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Nabil A Abd El-Mageed
state: DK
Study officials:
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Hazem E Moawed
role: STUDY_DIRECTOR
References: