| CTRI Number |
CTRI/2024/08/071988 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of intranasal dexmedetomidine on spinal anaesthesia shivering . |
|
Scientific Title of Study
|
Effect of intranasal dexmedetomidine on post spinal anaesthesia shivering during Cesarean delivery:A Randomized Clinical Trial |
| 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.Ponnada Naga Meghana |
| Designation |
Junior Resident |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology and CC,
SVIMS,
Tirupati.
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9573437969 |
| Fax |
|
| Email |
nagaponnada9498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and HOD |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Dr Aloka Samantaray,
MD, PDCC,
Professor and HOD ,
Department of Anaesthesiology and CC,
SVIMS,
Tirupati.
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and HOD |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Dr Aloka Samantaray ,
MD, PDCC,
Professor and HOD,
Department of Anaesthesiology and CC,
SVIMS,
Tirupati.
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences,Alipiri road,Tirupati-517501,Andhra Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Alipiri road, Tirupati- 517501, Andhra Pradesh,India |
| Type of Sponsor |
Other [Nil] |
|
|
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 Ponnada Naga Meghana |
Sri Venkateswara Institute of Medical Sciences |
Department of Anaesthesiology and CC,
SVIMS,
Alipiri road,
TIRUPATI,
517501.
Chittoor
ANDHRA PRADESH |
9573437969
nagaponnada9498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences, Tirumala Tirupati Devastanams,Tirupati.INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women between 20 to 45 years undergoing Elective or Emergency Cesarean delivery |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Dexmedetomidine |
Preoperative intranasal dexmedetomidine 1 mcg/kg diluted to 1 ml NS for post spinal anaesthesia shivering |
| Comparator Agent |
Normal Saline |
Preoperative intranasal NS 1 ml for post spinal anaesthesia shivering |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Age between 20-45 years.
2.ASA-PS II and III.
3.Weight between 45 to 75 kgs.
4.Normothermic 36.5 to 37.5 degree C
5.Stable hemodynamics SBP greater than 100mmhg. |
|
| ExclusionCriteria |
| Details |
1.Declining to participate or receive spinal anaesthesia.
2.Absolute contraindications to spinal anaesthesia.
3.Height less than 100 cms.
4.Morbid obesity with BMI greater than 40KG/M2 .
5.Known allergy to dexmedetomidine or bupivacaine.
6.Use of epidural catheter.
7.Presence of significant cardiac, liver or renal problems. |
|
|
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 DETERMINE THE OCCURENCE OF CLINICALLY SIGNIFICANT POST SPINAL ANAESTHESIA SHIVERING |
Immediately after spinal anaesthesia, 5,10,15,20,30,45,60 mins and at the end of the surgery.Post operative every 30 mins for 120 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GRADE OF SHIVERING
GRADE OF SEDATION
OCCURENCE OF NAUSEA,VOMITING,
BRADYCARDIA,HYPOTENSION. |
Immediately after spinal anaesthesia,post spinal at 1,3,5,10,20,30,40,50 min,1,2,4,6 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/08/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - .
- For how long will this data be available start date provided 01-08-2024 and end date provided 28-02-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Dexmedetomidine is a potent, selective alpha2-adrenoceptor agonist and promotes sedation, anxiety reduction, and analgesia without causing respiratory depression.
The administration of intravenous dexmedetomidine has been proved to be an effective measure to treat and prevent post spinal anaesthesia shivering.
This study is about the efficacy of intranasal dexmedetomidine for the control of post spinal anaesthesia shivering in patients undergoing cesarean delivery .
|