Comparison between the effects of intravenous clonidine and dexmedetomidine on shivering after spinal anaesthesia

Phase 4

Not yet recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2020/09/027985
• Lead Sponsor: Midnapore Medical College

Brief Summary

The aim of this study is to evaluateand compare the efficacy, haemodynamics and adverse effects of dexmedetomidinewith those of clonidine, when used for control of post spinal anaesthesiashivering during the intraoperative period. 54 American Society of Anaesthesiologistgrade I and II patients of either sex, aged 18-60 years, scheduled forsurgeries under spinal anaesthesia will be randomised into two groups of 27patients each. One group will receive dexmedetomidine 0.5mcg/kg , other groupwill receive clonidine 0.5mcg/kg. Grade of shivering, time of cessation ofshivering,  response rate, recurrence rate and adverse effects will beobserved at scheduled intervals.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-22
• Study Start: 2020-09-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Age- 18-60 years 2.
• ASA grade 1 & 2 3.
• OT temp between 24 to 32 degree 4.
• Gynaecology and obstetrics, surgery, and orthopaedic operations.

Exclusion Criteria

• Preexisting cardiac diseases 2.
• Pulmonary diseases 3.
• Bleeding or coagulation disorders 4.
• Renal or hepatic disease 5.
• Neuromuscular disorder 6.
• Psychiatric disorder 7.
• Hyperthyroidism 8.
• Deformity of the spinal column 9.
• Urinary tract infection 10.Severe diabetes or autonomic neuropathies 11.Known history of substance or alcohol abuse 12 Patient receiving any premedication 13.Cutaneous infection 14.Contraindication of spinal anaesthesia 15.Conversion to GA at any time intraoperatively 16.Patient refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will compare the effects of clonidine and dexmedetomidine on shivering in terms of time of cessation of shivering,	At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering.
response rate and recurrence rate of shivering following spinal anaesthesia	At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering.

Secondary Outcome Measures

Name	Time	Method
We will observe the change in blood pressure, heart rate, respiratory depression, nausea vomiting, dry mouth, effect of sedation in patients who will receive clonidine and dexmedetomidine separately.	At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering.

Trial Locations

Locations (1)

Midnapore medical college and hospital; 🇮🇳 Medinipur, WEST BENGAL, India

Midnapore medical college and hospital

🇮🇳Medinipur, WEST BENGAL, India

Mallika Mondal

Principal investigator

9007853882

molly12101988@gmail.com