A study to compare the effects of two different drugs(magnesium sulphate and dexmedetomidine) at reducing the blood pressure and heart rate during surgery for tumors of head and neck.
- Conditions
- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,
- Registration Number
- CTRI/2020/09/027630
- Lead Sponsor
- Christian Medical College
- Brief Summary
Primary tumour excision and selective neck dissection is the mainstay of treatment of oral cancers. The head and neck region is highly innervated and vascular and surgical stimulus causes an acceleration of the heart rate and blood pressure, resulting in increased bleeding and decreased visibility of the surgical field.
Controlled hypotensive anaesthesia is an accepted method of providing a drier operative field, better visualization, more accurate dissection and reduced blood loss. Management of the intraoperative pressor response during surgical stimulus in head and neck surgeries continues to be a challenge. Inhalational anaesthetics combined with various intravenous agents are used to provide controlled hypotension during surgery.
Various drugs have been used to reduce the pressor responses to noxious stimuli. Among these, the efficacy of dexmedetomidine, an α 2-adrenoreceptor agonist that reduces the heart rate and cardiac output, hence the blood pressure has been established. Magnesium Sulphate too reduces the blood pressure by inhibiting catecholamine release and arteriolar vasodilation. Studies comparing magnesium sulphate with dexmedetomidine shows conflicting conclusions of the advantage of one over the other. There are not many studies comparing the effect of these two drugs during selective neck dissection dissections. We would like to compare magnesium sulfate as a safe, effective and less expensive alternative to dexmedetomidine in our patient population undergoing head and neck surgery. Hence the need for this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 80
All patients (ASA I and II) coming for selective neck dissection surgeries.
- 1.Patient refusal 2.ASA III and IV , 3.GFR <90ml/mt/1.73m2 4.Patients on beta blockers and calcium channel blockers.
- 5.Known allergy to study drug 6.BMI >30 7.Vascular free flap surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of a bolus of either magnesium sulphate or Every five minutes from the time of infusion bolus dose dexmedetomidine on the hemodynamic response to surgical incision. Every five minutes from the time of infusion bolus dose
- Secondary Outcome Measures
Name Time Method 1) To compare the surgical field bleeding during neck dissection. 2) Comparison of duration of the attenuated pressor response..
Trial Locations
- Locations (1)
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Christian Medical College🇮🇳Vellore, TAMIL NADU, IndiaDivyalakshmi SPrincipal investigator7667756422divya231192@gmail.com