Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endoscopic Sinus Surgery

Intervention / Treatment
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* Drug: Propofol infusion
* Drug: Magnesium Sulfate infusion
* Drug: Lidocaine
* Drug: Fentanyl
* Drug: Propofol
* Drug: Atracurium
* Procedure: Mechanical Ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol infusion<br>Patients received intravenous Propofol infusion | Drug: Propofol infusion<br>* 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)<br>Drug: Lidocaine<br>* Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia<br>Drug: Fentanyl<br>* Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia<br>Drug: Propofol<br>* Patients will receive propofol in a dose of 1-2 mg /kg<br>Drug: Atracurium<br>* Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation<br>Procedure: Mechanical Ventilation<br>* 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<br>|
| Experimental: Magnesium Sulfate infusion<br>Patients received intravenous Magnesium Sulfate infusion | Drug: Magnesium Sulfate infusion<br>* 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<br>Drug: Lidocaine<br>* Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia<br>Drug: Fentanyl<br>* Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia<br>Drug: Propofol<br>* Patients will receive propofol in a dose of 1-2 mg /kg<br>Drug: Atracurium<br>* Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation<br>Procedure: Mechanical Ventilation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The number of patients will need nitroglycerine and dose | The number of patients will need nitroglycerine | at the end of the surgery | 
| Use of Ephedrine | The number of patients will need ephedrine | at the end of the surgery | 
| Need for blood transfusion | The number of patient need for blood transfusion | 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 | for the first hour postoperative | 
| Simplified post operative nausea and vomiting score | using impact scale score evaluation | for the first 24 hour postoperative | 
| Recovery time | time needed to reach modified aldrete score> or=9) | one hour after extubation | 
| Heart rate (HR) |  | 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 | 2 hours intraoperative |