Comparison of three commonly used drugs: Dexmedetomidine, Clonidine, and Magnesium Sulphate to find the best drug in reducing blood pressure, blood loss and improved surgical outcome during Sinus Surgery.
- Conditions
- Other specified disorders of noseand nasal sinuses, (2) ICD-10 Condition: O||Medical and Surgical,
- Registration Number
- CTRI/2022/10/046459
- Lead Sponsor
- Dr Akshatha G Kamath
- Brief Summary
This study is a double blinded,randomized control trial to compare Dexmedetomidine 0.75 µg/kg in 50 ml of saline over 20 minutes followed by 0.3-0.5 µg/kg/hour infusion, Clonidine 1.5 µg/kg in 50 ml of saline over 20 minutes followed by 0.3-0.5 µg/kg/hour infusion and Magnesium sulphate 25mg/kg over 20 minutes followed by an infusion at 5-10 mg/kg/hour for induced hypotension during functional endoscopic sinus surgery in patients belonging to ASA I and II physical status in St John’s medical College and Hospital, Bengaluru. Primary outcome will be comparing the efficacy of these drugs in inducing controlled hypotension. The secondary outcome will be assessing and comparing the improved surgical field visibility, analgesia and post-operative recovery with the use of these drugs.
This study is proposed to compare the efficacy of the three drugs in producing hypotension. Comparison of the three drugs and the resultant evidence may also help in identifying the drug that is more efficacious as well as cost effective.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 114
ASA I and II physical Status patients.
Hemodynamically unstable patients Uncontrolled hypertension/ coronary artery disease/ Heart blocks/ Autonomic neuropathy/ Renal dysfunction/ Hepatic dysfunction/ Cerebral insufficiency Patients allergic to the drugs being studied Patients with coagulopathy, bleeding disorders, platelet dysfunction Patients with vascular/congenital anomalies of nasal mucosa Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Dexmedetomidine, Clonidine and Magnesium Sulphate in inducing controlled hypotension Measured at baseline, after the loading dose, after induction, 1 minute after intubation, 5 minutes after intubation and thereafter every 10 minutes until shifting of the patient to the recovery area.
- Secondary Outcome Measures
Name Time Method Calculating the estimated blood loss Measured every 30 Minutes
Trial Locations
- Locations (1)
St Johns medical college and Hospital
🇮🇳Bangalore, KARNATAKA, India
St Johns medical college and Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Akshatha G KamathPrincipal investigator8197431985kamathakshatha9596@gmail.com