Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged between 18 to 60 yrs both male and female undergoing elective lower limb surgeries under spinal anaesthesia and reported shivering during surgery. 2.Belonging to American Society of Anaesthesiologists (ASA) Physical status I and II. 3.Patients whose BMI is in the range of 18 - 34.9 4.Patients who are willing to give consent to be a part of the study.
Exclusion criteria
Exclusion criteria: 1.Patients who do not develop shivering during surgery. 2.Patients with contraindications to regional anaesthesia. 3.Patients with history of hypersensitivity to amide local anaesthetics , dexmedetomidine and tramadol in the past. 4.Patients who have gone for complications during surgery like shock and prolonagtion of surgery more than 3 hrs. 5.Failure to decrease the shivering after repeated dosage more than 2 times. 6.Pregnant and lactating females. 7.Patients with hyperthyroidism, moderate to severe cardiopulmonary disease, hepatic failure psychiatric illness, renal failure, uncontrolled diabetes with autonomic neuropathy, severe bradycardia and hypotension. 8.Excessive hemorrhage needing transfusion . 9.Failure or incomplete spinal block. 10.Those with a known history of substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of IV Dexmedetomidine(0.5mcg/kg) and IV Tramadol(0.5mg/kg) for prevention of intraoperative shivering in patients undergoing lower limb surgeries under spinal anaesthesia. Onset of shivering Severity of shivering Duration of shivering Timepoint: Onset of sensory and motor blockade to be assessed every minute after giving Spinal Anaesthesia. Onset of shivering will be assessed every 5 min until it subsides or till maximum of 180 minutes intraoperatively. Total duration of shivering is assessed in each group in minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To study the hemodynamic parameters of Dexmedetomidine & Tramadol. 2.To compare the adverse effects of Dexmedetomidine & Tramadol in the subjects. Timepoint: 1. 0, 5, 10, 15,30 ,45 ,60 minutes & every half an hour thereafter till the end of surgery or till 180 mins. 2.hypotension, bradycardia, & nausea/vomiting intraoperatively & postoperatively will be assessed if occurs, till 180 minutes. | — |
Countries
India
Contacts
Rajiv Gandhi University of Health Sciences