| CTRI Number |
CTRI/2025/02/080845 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of subcutaneous dexmedetomidine for the prevention of shivering in patients undergoing cesarean delivery. |
|
Scientific Title of Study
|
Effect of subcutaneous dexmedetomidine in reducing shivering following cesarean section: a randomized control study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amarjeet Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Room No: 505, Department of Anaesthesiology, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amarjeet Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Room No: 505, Department of Anaesthesiology, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amarjeet Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Room No: 505, Department of Anaesthesiology, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, 5th floor IPD AIIMS Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department Of Anaesthesiology IPD 5th Floor |
| 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 Amarjeet Kumar |
AIIMS Patna |
Department Of Anaesthesiology
5th Floor IPD OT Complex AIIMS Patna 801507 Patna BIHAR
Patna
BIHAR |
9570890646
amarjeetdmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS PATNA |
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 group |
Will receive subcutaneous dexmedetomidine of dose 0.5 mcg/kg diluted with normal saline to total volume 1 ml just after delivery of the baby and cord clamping |
| Comparator Agent |
Normal saline group |
Will receive 1ml normal saline only |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaesthesiologists physical status 2,
Scheduled for Cesarean delivery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Pre-existing structural heart diseases
Eclampsia
Preeclampsia
Cesarean under general anesthesia
Psychiatric patient
History of convulsions
Patients received opioids/ tramadol for shivering management during intraoperative and postoperative periods
Patient underwent resurgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of shivering using patient rated 10 points VAS score after cesarean delivery |
At 30 minutes of postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity using Observer Rated 5 point Likert Scale |
At 30 minutes, 4 hours, 8 hours, 12 hours |
| Post operative pain using NRS score |
At 30 minutes, 4 hours, 8 hours, 12 hours |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
21/02/2025 |
| 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="0"
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
|
Previous studies documented that even though intravenous dexmedetomidine reduces the incidence of shivering, intravenous dexmedetomidine requires close monitoring, infusion pump and may be associated with adverse effects like Bradycardia, Hypotension and AV block.On injecting dexmedetomidine via subcutaneous route, it will allow its slow action and reduces complications rate in comparison to its intravenous injection. |