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Comparison of control of shivering occuring after giving spinal anesthesia by using regularly used opioids like butorphanol & tramadol

Efficacy of intravenous tramadol & butorphanol in the treatment of post spinal anesthesia shivering. A randomized controlled trial - not applicable

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056817
Enrollment
120
Registered
2023-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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 Health Condition 2: R688- Other general symptoms and signs

Interventions

Intervention1: Injection Tramadol: Injection Tramadol 0.5mg/kg slow IV diluted to 10ml with normal saline given over 20 seconds Intervention2: Injection Butorphanol: Injection Butorphanol 0.02mg/kg sl

Sponsors

Pondicherry Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients belonging to American society of anaesthesiologist physical status I & II. 2) Age between 18 to 60 years. 3) patient who develop shivering after spinal anaesthesia.

Exclusion criteria

Exclusion criteria: 1) Patients with hypo or hyperthyroidism 2) Patients with neuromuscular disease 3) Morbid obesity(body mass indexof=40kg/m2) 4) Fever(axillary temperature >37°C)and 5) Compromised cardio respiratory functions 6) Patients on long term phenothiazines & MAO inhibitors 7) Patients with hepatic & renal insufficiency 8) Allergy to any of the study drugs

Design outcomes

Primary

MeasureTime frame
Grade of shivering. Complete/incomplete Control of shivering. Time taken for control of shivering Recurrence of shivering Parameters like heart rate, Blood pressure, oxygen saturation and temperatureTimepoint: 1)Parameters will be seen at intervals of 1 minute for the first 5 minutes and thereafter 10,15,20,25,30,40,60 minutes till cessation of shivering. 2)Tympanic membrane temperature will be noted at shivering, and regular intervals of 15,30,45 minutes following shivering. 3)Control of shivering and grading of shivering will be noted for 20 mins

Secondary

MeasureTime frame
Complete or incomplete Control of shivering. Time taken for control of shivering Recurrence of shivering Parameters like heart rate, Blood pressure, oxygen saturation & temperatureTimepoint: 20 min

Countries

India

Contacts

Public ContactDr Vidya M V

Pondicherry Institute of Medical Sciences

drmvvidya@gmail.com9585550838

Outcome results

None listed

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