Study for Comparison between Tramadol and dexmedetomidine for treatment of post-spinal anaesthesia shivering

Not yet recruiting

• Conditions: Osteopathic,

• Registration Number: CTRI/2021/03/032090
• Lead Sponsor: Dr DYPatil Hospital

Brief Summary

To compare efficacy of dexmedetomidine versus tramadol for control of post-spinal anaesthesia shivering.

To compare the perioperative variations in hemodynamic parameters and the incidence of adverse effects among the groups.

Dexmedetomidine (α2 adrenergic agonist) has been used for prevention of post anaesthesia shivering. Its use for the treatment of post-spinal anaesthesia shivering has not been evaluated. The aim of this study is to evaluate and compare the efficacy, haemodynamic and adverse effects of dexmedetomidine with those of tramadol, when used for control of post-spinal anaesthesia shivering.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-03-13
• Study Start: 2021-04-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patient giving consent >patients of either gender aged 18-65 years scheduled for elective lower abdominal, lower limb surgeries under spinal anaesthesia >American Society of Anesthesiologist physical status class I and II.

Exclusion Criteria

• •Patients with known hypersensitivity to dexmedetomidine or tramadol, cardio-pulmonary, renal or hepatic disease, hyperthyroidism, psychiatric disorder, urinary tract infection, severe diabetes or autonomic neuropathies, known history of substance or alcohol abuse, patients receiving any pre-medication.
• •cesarean section.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cessation of shivering , Episodes of recurrence	shivering ceasing within 15 min after treatment , time of recurrence after treatment

Secondary Outcome Measures

Name	Time	Method
Adverse effects such as nausea, vomiting, bradycardia (50/min), hypotension (20% of baseline), dizziness; and sedation score will be noted. The degree of sedation will be graded on a four-point scale as Grade 1: Awake and alert, Grade 2: Drowsy, responsive to verbal stimuli, Grade 3: Drowsy, arousable to physical stimuli, Grade 4: Unarousable	every 15 min interval hemodynemic changes

Trial Locations

Locations (1)

Dr D.Y.Patil Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Dr D.Y.Patil Hospital

🇮🇳Thane, MAHARASHTRA, India

DR PARTH

Principal investigator

7874213149

parth9087@gmail.com