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

Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032090
Enrollment
100
Registered
2021-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: 7- Osteopathic

Interventions

Intervention1: dexmedetomidine 0.5 mcg/kg tramadol 0.5mg /kg: patient developing shivering after spinal anaesthesia intervened randomly by Dexmedetomidine -0.5 mcg/kg or Tramadol- 0.5 mg/kg , slow si

Sponsors

Dr DYPatil Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
cessation of shivering , Episodes of recurrenceTimepoint: shivering ceasing within 15 min after treatment , time of recurrence after treatment

Secondary

MeasureTime frame
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: UnarousableTimepoint: every 15 min interval hemodynemic changes

Countries

India

Contacts

Public ContactDr varsha vyas

DR D Y PATIL MEDICAL COLLEGE NAVI MUMBAI

varsha.vyas011@gmail.com9819583232

Outcome results

None listed

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