Endoscopic Sinus Surgery
Conditions
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.
Interventions
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)
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
DRUGLidocaine
Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
DRUGFentanyl
Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
DRUGPropofol
Patients will receive propofol in a dose of 1-2 mg /kg
DRUGAtracurium
Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation
PROCEDUREMechanical 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
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The number of patients will need nitroglycerine and dose | at the end of the surgery | The number of patients will need nitroglycerine |
| 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 |
| 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) |
| Recovery time | one hour after extubation | time needed to reach modified aldrete score\> or=9) |
| Heart rate (HR) | 15 minutes after the start of the hypotensive agent | — |
| 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 |
| Simplified post operative nausea and vomiting score | for the first 24 hour postoperative | using impact scale score evaluation |
Countries
Egypt
Contacts
Primary ContactNabil A Abd El-Mageed, MD
Backup ContactHazem E Moawed, MD
Outcome results
None listed