| CTRI Number |
CTRI/2025/09/095027 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of different doses of Dexmedetomidine for the treatment of shivering in patients undergoing C-section under Spinal Anaesthesia |
|
Scientific Title of Study
|
Comparative Evaluation of different doses of Dexmedetomidine for the treatment of shivering in parturients undergoing Caesarean section under Subarachnoid block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Arya |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main Operation Theatre Building Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
7060638576 |
| Fax |
|
| Email |
poojaaryaa960@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main Operation Theatre Building Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
DELHI
110029
|
| Phone |
09910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main Operation Theatre Building Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
|
| Phone |
09910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College And Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Safdarjung Hospital, Ansari Nagar East, New Delhi |
| Type of Sponsor |
Government 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 Pooja Arya |
VMMC and Safdarjung Hospital |
Department of Anaesthesiology and Intensive Care, Ground floor Main Ot Block
South West
DELHI |
7060638576
poojaaryaa960@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical college and Safdarjung Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.35microgram/kg i.v Dexmedetomidine and 0.4microgram/kg of inj. Dexmedetomidine. |
We are trying to compare single intravenous dose of 0.35mcg/kg and 0.4mcg/kg dose of inj. Dexmedetomidine to treat shivering in patients during c-section under spinal anaesthesia.We will monitor the patient for next 10 minutes for decrease in shivering score and next 45 minutes for hemodynamic changes and sedation. |
| Intervention |
i.v Dexmedetomidine o.3 microgram/kg |
We are trying to evaluate 0.3mcg/kg dose of inj. Dexmedetomidine to treat shivering in patients during c-section under spinal anaesthesia. We will monitor the patient for next 10 minutes for decrease in shivering score and next 45 minutes for hemodynamic changes and sedation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade 2 gestational age more than equal to 37 weeks scheduled for elective c-section under subarachnoid block who present with shivering. |
|
| ExclusionCriteria |
| Details |
Parturients with
Height less than 150cm or more than 170 cm
Initial body temperature of more than 38 degree Celsius or less than 36 degrees Celsius.
Chronic user of adrenergic receptor blockers or calcium channel blockers.
Known history of alcohol or substance abuse or post-partum hemorrhage |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shivering scores in groups with different dexmedetomidine doses
|
Reduction of Shivering scores within 10 minutes in groups with different dexmedetomidine doses assessed by Crossley Et al shivering score. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time taken for reduction of shivering score less than one after inj. dexmedetomidine
2.Duration of anti shivering effect.
3.Measurement of MAP,HR,SPO2,temperature at different time intervals.
4. Assessment of sedation.
5. Dose of rescue anti shivering drug. |
Assessment of sedation with Ramsay Sedation Score every 5 minutes intervals at 5 minutes after dexmedetomidine injections for total 45 minutes. |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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)
|
28/09/2025 |
| 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
|
After caesarean delivery shivering can cause maternal discomfort and can interfere with oxygen saturation electrocardiogram and blood pressure monitoring. Therefore, developing strategies for treating shivering may improve the care that we provide to our parturient. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, is considered a valuable medication in the current obstetric anaesthesia. Here we are trying to compare the efficacy of three different doses of Dexmedetomidine for the treatment of shivering in patients undergoing caesarean section under spinal anaesthesia. The Methodology and administration of drug shall be explained in detail with a written informed consent from the patient. The parturients will be divided into three groups of 41 each using block randomisation technique ( Group D1 will receive 0.3 mcg/kg of i.v dexmedetomidine on occurrence of shivering, Group D2 will receive 0.35mcg/kg of i.v dexmedetomidine and Group D3 will receive 0.4 mcg/ kg of i.v dexmedetomidine when they present with shivering).Patient will be taken in OT and standard monitoring will be attached and baseline vital parameters will be noted. A subarachnoid block will be performed in lateral decubitus position. On occurrence of shivering patient will be given allocated group drug and will be observed for 45 minutes. Shivering score, hemodynamic parameters, Sedation Score, time taken to reduce shivering score, duration of antishivering effect and dose of rescue antishivering drug if given shall be noted. Side effects related to dexmedetomidine injection will be recorded and treated. |