| CTRI Number |
CTRI/2026/03/106221 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Preventing shivering after spinal anaesthesia: A comparison of two medications. |
|
Scientific Title of Study
|
Status of post spinal anaesthesia shivering in urological surgeries with intrathecal Dexmedetomidine vs intrathecal Magnesium sulfate. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swetha K |
| Designation |
Postgraduate student |
| Affiliation |
Madurai Medical College |
| Address |
No 121, Institute of Anesthesiology, Anaesthesia division, Government Rajaji Hospital and Madurai Medical College, Madurai-625020.
TamilNadu,India.
Madurai
TAMIL NADU
625020
India |
| Phone |
9952836624 |
| Fax |
|
| Email |
swethareshhh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Velmurugan B MD DA |
| Designation |
Professor Institute of Anaesthesiology Madurai Medical College |
| Affiliation |
Madurai Medical College |
| Address |
No 121, Institute of Anesthesiology, Anaesthesia division, Government Rajaji Hospital and Madurai Medical College, Madurai-625020.
TamilNadu,India.
33,Shri Jayashree Apartments-2,A8 First floor,Bharathi Ula road,Racecourse,Madurai 625002
Madurai
TAMIL NADU
625020
India |
| Phone |
9787714295 |
| Fax |
|
| Email |
dr.b.velmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Velmurugan B MD DA |
| Designation |
Professor Institute of Anaesthesiology Madurai Medical College |
| Affiliation |
Madurai Medical College |
| Address |
No 121, Institute of Anesthesiology, Anaesthesia division, Government Rajaji Hospital and Madurai Medical College, Madurai-625020.
TamilNadu,India.
33,Shri Jayashree Apartments-2,A8 First floor,Bharathi Ula road,Racecourse,Madurai 625002
TAMIL NADU
625020
India |
| Phone |
9787714295 |
| Fax |
|
| Email |
dr.b.velmurugan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Anaesthesiology,Madurai medical college. |
| Address |
147A, Sri Renganathar Nagar,Meenavilakku,B Anaikaraipatti,Meenakshipuram,Bodinayakkanur,Theni,Tamilnadu-625582 |
| Type of Sponsor |
Other [self] |
|
|
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 Swetha K |
Government Rajaji Hospital and Madurai medical college |
OT complex, super-speciality block,Urology OT
Madurai
TAMIL NADU |
9952836624
swethareshhh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MADURAI MEDICAL COLLEGE AND GOVERNMENT RAJAJI HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control agent |
Using Normal Saline 0.5ml as a control agent as a single intrathecal administration at the time of spinal anaesthesia. |
| Intervention |
Intrathecal Dexmedetomidine |
To study the efficacy and safety profile of intrathecal dexmedetomidine in preventing post spinal anaesthesia shivering. Dexmedetomidine is an alpha-2 agonist group of drug used in a dose of 5 microgram as a single intrathecal administration at the time of spinal anaesthesia. |
| Comparator Agent |
Intrathecal Magnesium Sulfate |
To study the efficacy and safety profile and to compare it with Dexmedetomidine in preventing post spinal anaesthesia shivering. Inj Magnesium sulfate is used in a dose of 50mg as a single intrathecal administration at the time of spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II, undergoing elective urologic surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Coagulopathy, allergy to local anaesthetics, severe cardiac, respiratory, hepatic or renal disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and intensity of shivering |
From administration of spinal anaesthesia until 120 minutes intraoperatively or end of surgery, whichever occurs erlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of adverse effects like nausea, vomiting, hypotension, hypothermia, sedation. |
Intraoperative till 2 hours postoperative |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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 Applicable |
| 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
|
Post spinal anaesthesia shivering is a common complication encountered during surgeries performed under spinal anaesthesia, particularly in urological procedures. This study aims to compare the effectiveness of intrathecal dexmedetomidine and intrathecal magnesium sulfate as adjuvants to hyperbaric bupivacaine in preventing post spinal anaesthesia shivering. Dexmedetomidine is an alpha 2 adrenergic agonist, is known to reduce the thermoregulatory shivering threshold and provide mild sedation, while magnesium sulfate acts as an NMDA receptor antagonist and modulates thermoregulation. |