Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery
- Conditions
- Endoscopic Sinus Surgery
- Interventions
- Drug: Magnesium Sulfate infusionProcedure: Mechanical Ventilation
- Registration Number
- NCT04078659
- Lead Sponsor
- Mansoura University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- American Society of Anesthesiologists Physical Classes I or II
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol infusion Propofol infusion Patients received intravenous Propofol infusion Magnesium Sulfate infusion Lidocaine Patients received intravenous Magnesium Sulfate infusion Magnesium Sulfate infusion Mechanical Ventilation Patients received intravenous Magnesium Sulfate infusion Propofol infusion Mechanical Ventilation Patients received intravenous Propofol infusion Magnesium Sulfate infusion Magnesium Sulfate infusion Patients received intravenous Magnesium Sulfate infusion Propofol infusion Fentanyl Patients received intravenous Propofol infusion Propofol infusion Lidocaine Patients received intravenous Propofol infusion Propofol infusion Propofol Patients received intravenous Propofol infusion Propofol infusion Atracurium Patients received intravenous Propofol infusion Magnesium Sulfate infusion Fentanyl Patients received intravenous Magnesium Sulfate infusion Magnesium Sulfate infusion Propofol Patients received intravenous Magnesium Sulfate infusion Magnesium Sulfate infusion Atracurium Patients received intravenous Magnesium Sulfate infusion
- Primary Outcome Measures
Name Time Method Mean arterial blood pressure (MAP) 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
- Secondary Outcome Measures
Name Time Method Heart rate (HR) 15 minutes after the start of the hypotensive agent The blood loss at the end of the surgery The blood loss would be calculated using the following formula Blood Loss = Blood Volume. In )Hct 1 / Hct2)
Use of Ephedrine at the end of the surgery The number of patients will need ephedrine
Need for blood transfusion at the end of the surgery The number of patient need for blood transfusion
Postoperative Ramsey sedation 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
Recovery time one hour after extubation time needed to reach modified aldrete score\> or=9)
The number of patients will need nitroglycerine and dose at the end of the surgery The number of patients will need nitroglycerine
Simplified post operative nausea and vomiting score for the first 24 hour postoperative using impact scale score evaluation
surgical field assessment 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
Trial Locations
- Locations (1)
Nabil A Abd El-Mageed
🇪🇬Mansoura, DK, Egypt