Comparison on the effect of intravenous Tramadol and low-dose Ketamine in controlling post -spinal anaesthesia shivering following caeserean section
- Conditions
- Other complications of anesthesiaduring labor and delivery,
- Registration Number
- CTRI/2023/08/056964
- Lead Sponsor
- Merlin Marita Loving
- Brief Summary
This study will be a randomized double blinded study to compare the effect of intravenous tramadol (0.5mg/kg) and low-dose ketamine (0.2mg/kg) in the control of post-spinal anaesthesia shivering in the parturient undergoing caesarean section.
​A total number of 72 pregnant women, ASA physical status I and II patients who will be undergoing caesarean section shall be enrolled in the study. The patients will be divided into two groups of 36 each. The study drugs will be prepared in 5 ml syringe by an anesthesiologist not directly involved in the study to keep the study double blinded. Group T (n=37) will receive intravenous tramadol 0.5mg/kg diluted to 5ml (with normal saline) and Group K (n=37) will receive intravenous low-dose ketamine 0.2mg/kg diluted to 5ml (with normal saline) with the onset of post-spinal anaesthesia shivering. Inj. bupivacaine will be used as spinal drug for spinal anesthesia. The operating room temperature will be maintained at an ambient temperature of around 24°C-28°C. Vitals parameters like temperature, blood pressure, mean arterial pressure, heart rate and SpO2 will be recorded preoperatively and intraoperatively. Time of onset of shivering along with its grade and the disappearance of shivering will be recorded. In case of failure to control shivering by study drugs Inj. Pethidine(25mg) will be used as rescue drug.
The data collected will be analysed and interpreted by appropriate statistical method. Quantitative data will be analysed using Student’s t-test and qualitative data will be analysed using Chi-square test. P value < 0.05 will be taken as significant
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 72
1.Pregnant women of age group 18-45 years  2.Patients of ASA I or II.
- Patients with history of allergy to the study drugs (tramadol, ketamine) 2.
- Patients with history of diabetes, hypertension, cardiovascular, respiratory, renal or neurological disease      3. Patients with spinal deformity 4. Patients with local site infection 5.
- Patients with bleeding disorder- platelet count <50,000/microlitre, prothrombin time >14 sec, International normalized ratio (INR) > 1.5.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Control of Shivering Outcome will be assessed after the administration of ketamine | & Tramadol Data will be assessed at the end of one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Regional Institute of Medical Sciences
🇮🇳West, MANIPUR, India
Regional Institute of Medical Sciences🇮🇳West, MANIPUR, IndiaDr Merlin Marita LovingPrincipal investigator9495281474merlinmarita1@gmail.com