Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery

Endoscopic Sinus Surgery Clinical Trial

Official title:

Controlled Hypotension During Endoscopic Sinus Surgery: A Comparison of Propofol and Magnesium Sulfate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04078659
• Other study ID #: MS /18.08.247
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: February 2020

Study information

• Verified date: September 2019
• Source: Mansoura University
• Contact: Nabil A Abd El-Mageed, MD
• Phone: 00201001538648
• Email: nabil-abdelraouf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Sinus Surgery

Intervention

Drug:
• 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)
• Magnesium Sulfate infusion
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
• Lidocaine
Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
• Fentanyl
Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
• Propofol
Patients will receive propofol in a dose of 1-2 mg /kg
• Atracurium
Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation

Procedure:
• Mechanical Ventilation
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

Locations

Country	Name	City	State
Egypt	Nabil A Abd El-Mageed	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 minutes after the induction of the hypotensive agent
Secondary	The blood loss	The blood loss would be calculated using the following formula Blood Loss = Blood Volume. In )Hct 1 / Hct2)	at the end of the surgery
Secondary	The number of patients will need nitroglycerine and dose	The number of patients will need nitroglycerine	at the end of the surgery
Secondary	Use of Ephedrine	The number of patients will need ephedrine	at the end of the surgery
Secondary	Need for blood transfusion	The number of patient need for blood transfusion	at the end of the surgery
Secondary	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	for the first hour postoperative
Secondary	Simplified post operative nausea and vomiting score	using impact scale score evaluation	for the first 24 hour postoperative
Secondary	Recovery time	time needed to reach modified aldrete score> or=9)	one hour after extubation
Secondary	Heart rate (HR)		15 minutes after the start of the hypotensive agent
Secondary	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	2 hours intraoperative