| CTRI Number |
CTRI/2026/04/108570 [Registered on: 16/04/2026] Trial Registered Prospectively |
| Last Modified On: |
15/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Evaluation of Dexmedetomidine, Ketamine and Magnesium Sulphate for treatment of Perioperative Shivering after Spinal Anaesthesia |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine, Ketamine and Magnesium Sulphate for treatment of Perioperative Shivering after Spinal Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devam Himanshu Trivedi |
| Designation |
Junior Resident |
| Affiliation |
JSS Academy Of Higher Education And Reasearch |
| Address |
Department Of Anesthesiology JSS Hospital, Mysore, Karnataka
Mysore
KARNATAKA
570004
India |
| Phone |
7069010268 |
| Fax |
|
| Email |
devamdev@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Devam Himanshu Trivedi |
| Designation |
Junior Resident |
| Affiliation |
JSS Academy Of Higher Education And Reasearch |
| Address |
Department Of Anesthesiology JSS Hospital, Mysore, Karnataka
Mysore
KARNATAKA
570004
India |
| Phone |
7069010268 |
| Fax |
|
| Email |
devamdev@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana K N |
| Designation |
Professor |
| Affiliation |
JSS Academy Of Higher Education and Research |
| Address |
Department Of Anaesthesiology, JSS Hospital, Mysore, Karnataka
Mysore
KARNATAKA
570004
India |
| Phone |
9845140637 |
| Fax |
|
| Email |
knarchana@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JSS Academy Of Higher Education And Research |
| Address |
JSS Medical College And Hospital, Mysore, Karnataka 570015 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devam Himanshu Trivedi |
JSS Medical College And Hospital |
Patients Undergoing Spinal Anaesthesia in OT Complex JSS Hospital MG Road, Agrahara, Mysore, Karnataka
Mysore
KARNATAKA |
7069010268
devamdev@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE IV |
Inj DEXMEDETOMIDINE 0.5 MCG/KG IV over 10 minutes |
| Intervention |
KETAMINE IV |
Inj KETAMINE 0.5 MG/KG IV bolus |
| Intervention |
MAGNESIUM SULPHATE IV |
Inj MAGNESIUM SULPHATE 50 MG/KG IV over 10 minutes |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18 to 60 years of ASA grade 1, 2 and 3 undergoing elective surgery under spinal anaesthesia with grade 2 and above shivering |
|
| ExclusionCriteria |
| Details |
1. Patients with ASA physical status above 3.
2. Patients allergic or contraindicated to study medication.
3. Patients with severe cardio pulmonary disease, renal or liver impairment, peri operative fever or hypothermia, history of seizure, massive blood transfusion and history of psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Dexmedetomidine, Ketamine, Magnesium Sulphate in the treatment of peri operative shivering subsequent to spinal Anesthesia |
After study drug administration shivering grade will be assessed at 1, 3, 5 minutes and thereafter every 5 minutes till shivering resolves or 30 minutes has elapsed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the hemodynamic parameters after giving the study drugs.
2. To compare side effects of the drugs including nausea, vomiting, hypotension, hypertension, bradycardia, tachycardia, sedation, respiratory depression, delirium, hypothermia. |
After administration of the study drug all secondary outcomes will be assessed at 1, 3, 5 minutes & thereafter every 5 minutes till 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective double blind randomized clinical trial to compare dexmedetomidine ketamine and magnesium sulphate for the treatment of perioperative shivering following spinal anesthesia. Adult patients aged 18 to 60 years who develop grade 2 or 3 shivering after spinal anesthesia will be randomly allocated into three groups. Each group will receive a single intravenous bolus of either dexmedetomidine 0.5 microgram per kg ketamine 0.5 mg per kg or magnesium sulphate 50 mg per kg at the onset of shivering. The time taken for reduction of shivering to grade 0 or 1 will be recorded. Patients will be monitored for heart rate mean arterial pressure oxygen saturation temperature and sedation score at regular intervals. Recurrence of shivering and adverse effects such as nausea vomiting hypotension bradycardia respiratory depression delirium and hypothermia will also be recorded.
|