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

Phase 2/3

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: R688||Other general symptoms and signs,

• Registration Number: CTRI/2023/08/056817
• Lead Sponsor: Pondicherry Institute of Medical Sciences

Brief Summary

This primary purpose of the study is to compare the efficacy of intravenous tramadol(0.5mg/kg) and butorphanol(0.02mg/kg) in the treatment of post spinal anaesthesia shivering. A double blinded randomised control trial. We Hypothesise that butorphanol has early onset of control of shivering compared to tramadol.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-09
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade of shivering.	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
Complete/incomplete Control of shivering.	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
Time taken for control of shivering	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
Recurrence of shivering	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
Parameters like heart rate, Blood pressure, oxygen saturation and temperature	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 Outcome Measures

Name	Time	Method
Complete or incomplete Control of shivering.	Time taken for control of shivering

Trial Locations

Locations (1)

Pondicherry Institute of Medical Sciences; 🇮🇳 Pondicherry, PONDICHERRY, India

Pondicherry Institute of Medical Sciences

🇮🇳Pondicherry, PONDICHERRY, India

Dr MV Vidya

Principal investigator

9585550838

drmvvidya@gmail.com