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A Study on evaluation of efficacy of Dexmedetomidine an Tramadol for attenuation of post Spinal Anesthesia shivering during lower limb surgery

Comparative evaluation of Dexmedetomidne and Tramadol for attenuation of post-spinal Anaesthesia shivering during lower limb surgeries: A Randomized Double-Blinded Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068892
Enrollment
100
Registered
2024-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine: To compare the efficacy of Intravenous Dexmedetomidine(0.5mcg/kg) and Intravenous Tramadol(0.5mg/kg) to decrease intraoperative shivering in patients undergoing lower

Sponsors

Gulbarga Institute of Medical Sciences
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Praveen Kumar DP

Rajiv Gandhi University of Health Sciences

mdmukarramiqbal@gmail.com9035801586

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026