| CTRI Number |
CTRI/2025/09/094895 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How to prevent shivering During Spinal Anaesthesia in Urology Patients: A comparison of three drugs DEXMEDETOMIDINE , DEXAMETHASONE AND MAGNESIUM SULPHATE . |
|
Scientific Title of Study
|
Comparative study of intravenous administration of Dexmedetomidine ,
Dexamethasone and Magnesium Sulphate in prevention of shivering in urological surgeries done under 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 |
Dr. Artan Preet Kaur |
| Designation |
1st year PG resident anaesthesiology |
| Affiliation |
Adesh Institute of Medical Sciences and Reseach . Bathinda . |
| Address |
Room no.8 Ground floor Adesh Institute of Medical sciences and research Department of Anaesthesiology & Intensice care
Bathinda Punjab 151001 India
PUNJAB
151001
India
Room no.8 Ground floor
Department of Anaesthesiology &
Intensice care Adesh Institute of Medical sciences and Research
Bathinda Punjab 151001 India
Bathinda
PUNJAB
151001
India |
| Phone |
7652906911 |
| Fax |
|
| Email |
artan18020preet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minnu Panditrao |
| Designation |
Professor, Department of Anaesthesiology and Intensive care, AIMSR, Bathinda |
| Affiliation |
Adesh Institute of Medical Sciences and Reseach (AIMSR). Bathinda |
| Address |
Department of Anaesthesiology and Intensive Care Adesh Institute Of Medical Sciences And Research
Bathinda
PUNJAB
151001
Department of Anaesthesiology and Intensive Care Adesh Institute Of Medical Sciences And Research Bathinda Punjab 151001 India Bathinda
PUNJAB
151001
Bathinda
PUNJAB
151001
India |
| Phone |
8699943250 |
| Fax |
|
| Email |
drmmprao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Artan Preet Kaur |
| Designation |
Ist Year PG resident Anaesthesiology |
| Affiliation |
Adesh Institute of Medical Sciences and Reseach ( AIMSR) . Bathinda |
| Address |
Room No. 8 Ground floor Adesh Institute of Medical sciences and
research Bathinda Department of Anaesthesiology and Intensive
care
Bathinda
PUNJAB
151001
India
Room No. 8 Ground floor Adesh Institute of Medical sciences and
research Bathinda Department of Anaesthesiology and Intensive
care
Bathinda
PUNJAB
151001
India
Bathinda
PUNJAB
151001
India |
| Phone |
7652906911 |
| Fax |
|
| Email |
artan18020preet@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Hospital, Department of Anaesthesiology And Intensive Care . Adesh Institute of Medical Sciences and Research .Bathinda . 151001. Punjab . India |
|
|
Primary Sponsor
|
| Name |
Adesh Institute of medical sciences and research Bathinda |
| Address |
Adesh institute of medical sciences and research Bathinda
151001
punjab
india
|
| 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 |
| Artan Preet Kaur |
Adesh Institute of medical sciences and Research, Bathinda |
main operating theatre complex Department of
Anaesthesiology and
intensive care Adesh
institute of medical
sciences and research
(AIMSR) Bhucho Khurd
Barnala road Bathinda
151001
Bathinda
PUNJAB
Bathinda
PUNJAB |
07652906911
artan18020preet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committe , Adesh University , Bathinda . |
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 |
| Comparator Agent |
DEXAMETHASONE |
Spinal anaesthesia will be administered following the standard protocol , after confirming adequate sensory block , dexamethasone 0.6 mg/kg in 100 ml Ns will be infused IV over 10 minustes |
| Intervention |
DEXMEDETOMIDINE
|
spinal anaesthesia will be administered following the standard protocol ,after confirming adequate sensory block ( T10 level), dexmedetomidine 0.5 mcg/kg in 100 ml NS will be infused IV over 10 minutes . |
| Comparator Agent |
MAGNESIUM SULPHATE |
Spinal anaesthesia will be administered following the standard protocol, after confirming adequate sensory block (T10 Level ) , Magnesium sulphate 50 mg/kg in 100 ml NS will be infused IV over 10 mins . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-65 years
ASA Grading I & II
Patients undergoing elective urological surgeries under spinal anaesthesia
Both genders |
|
| ExclusionCriteria |
| Details |
Emergency surgeries
Known hypersensitivity to any of the agents used in the study
Patients with uncontrolled hypertension, diabetes mellitus, or thyroid disorders
Patients with cardiovascular, respiratory, hepatic, or renal impairment ( moderate to severe )
Patients on alpha-adrenergic receptor antagonists, calcium channel blockers, or on chronic steroid therapy
Patients with a history of alcohol or drug abuse
Patients with psychiatric disorders
Non-consenting patients |
|
|
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 intravenous dexmedetomidine, dexamethasone,
and magnesium sulphate for prevention of shivering after spinal anaesthesia in urological surgeries. |
o Baseline vitals(before spinal anesthesia)
o 10 minutes after spinal anesthesia (before drug administration)
o Every 10 minutes after drug administration until the end of surgery
o At the completion of surgery and 30 minutes post-surgery in the recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the hemodynamic changes with the use of these drugs.
2. To monitor and compare the incidence and severity of side effects/complications with the
use of these drugs.
3. To assess the level of sedation associated with each intervention. |
0 mins
10 mins
20 mins
30 mins
40 mins
50 mins
60 mins
at the end of surgery |
|
|
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)
|
06/10/2025 |
| 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 designed to compare the effectiveness of IV dexmedetomidine , dexamethasone and magnesium sulphate in preventing shivering in patients undergoing urological studies under spinal anaesthesia . The trail evaluates the incidence , severity and haemodynamic stability associated with each drug . In this trail patients will be randomly allocated into 3 groups , spinal anaesthesia will be given and after confirming the adequate sensory block the study drug will be given and then the observations will be noted . |