Effect of dexmedetomidine and magnesium sulphate on propofol consumption, haemodynamics (blood pressure and heart rate) and postoperative recovery in spine surgery
- Conditions
- ASA grade I or II patient, Non diabetic, Non hypertensive and require General anesthesia with intubation
- Registration Number
- CTRI/2013/08/003939
- Lead Sponsor
- Apollo Hospitals Bilaspur
- Brief Summary
Magnesium sulphate and dexmedetomidine have been used during surgery with the intention to maintain haemodynamic stability, decrease anesthetic requirement and improved postoperative recovery in general anesthesia.
Aim - To evaluate the efficacy of dexmedetomidine and magnesium sulphate on propofol consumption, haemodynamics and postoperative recovery in spine surgery.
Desigh - Prospective, randomized, placebo controlled double blinded study
Methods - Ninety patients of both gender undergoing spine surgery under general anesthesia will be randomly assigned to three groups. Group I - Dexmedetomidine loading dose 1 mcg/kg before induction over a period of 15 min and maintenance 0.5 mcg/kg/h throughout the surgery. Group II- Magnesium sulphate loading dose 50 mg/kg before induction over a period of 15 min and maintenance 15 mg/kg/h throughout the surgery. Group III - The same volume of normal saline will be administered . Anesthesia will be induced with midazolam, fentanyl, propofol and vecuronium after 5 min of loading dose of study drug. Anesthesia will be maintained with oxygen, nitrous oxide, intermittent boluses of vecuronium and fentanyl. Neuromuscular blockade will be reversed after completion of surgery. A blinded observer will be recorded haemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure and mean blood pressure) and propofol consumption. Statistical analysis will be done after completion of surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
1.ASA grade I and II, 2.Non hypertensive and non diabetic 3.Scheduled for spinal surgery under general anesthesia.
1.Known allergy to magnesium sulphate or other study drug, 2.Morbid obesity (body mass index>40), 3.Chronic use of opioids and anticoagulants 4.Current treatment with a β-blocker or calcium channel blocker 5.Diabetes and hypertension 6.Known asthma or reactive airway disease, 7.Hepatic, renal or cardiovascular dysfunction 8.Any degree of heart block 9.Haematological disorder 10.History of neuromuscular disease, 11.Patients receiving magnesium supplementation, 12.Drugs known to have a significant interaction with NMDAs 13.Psychiatric patients 14.Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the effect of dexmedetomidine and magnesium sulphate on propofol consumption and haemodynamics in spine surgery. (A) Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and bispectral index (BIS) will be continuously monitored and recoreded at following time intervals | 1)Preop | 2)After study drug | 3)After induction | 4)After intubation | 5)Intraop period at 20 min intervals | 6)After surgery | 7) After extubation | (B) Propofol requirement hourly
- Secondary Outcome Measures
Name Time Method (1)Postoperative recovery parameters - Extubation time –
Trial Locations
- Locations (1)
Apollo Hospitals Bilaspur
🇮🇳Bilaspur, CHHATTISGARH, India
Apollo Hospitals Bilaspur🇮🇳Bilaspur, CHHATTISGARH, IndiaDr Vinit Kumar SrivastavaPrincipal investigator9755557539drvinit75@gmail.com