| CTRI Number |
CTRI/2024/04/065859 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of vital sign parameter like perfusion index and to see requirement of medicine phenylephrine to maintain blood pressure in patient undergoing caesarean section under spinal anaesthesia. |
|
Scientific Title of Study
|
Perfusion index as predictor of hypotension following spinal anaesthesia in patients undergoing caesarean section for use of prophylactic phenylephrine. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya |
| Designation |
Postgraduate junior resident 2 |
| Affiliation |
Sgt medical college and research institute |
| Address |
Department of Anaesthesia first floor OT complex SGT medical college and research institute budhera gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9552315624 |
| Fax |
|
| Email |
Divyaahlawat5400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Saini |
| Designation |
Professor Department of Anaesthesia |
| Affiliation |
SGT Medical college and research institute |
| Address |
Department of Anaesthesia first floor OT complex SGT medical college and research institute budhera gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9416262343 |
| Fax |
|
| Email |
dr_savitasaini@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Saini |
| Designation |
Professor Department of Anaesthesia |
| Affiliation |
SGT Medical college and research institute |
| Address |
Department of Anaesthesia OT Complex first floor SGT medical college and research institute budhera gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9416262343 |
| Fax |
|
| Email |
dr_savitasaini@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sgt medical college and hospital research institute near Budhera Gurugram Haryana 122505 |
|
|
Primary Sponsor
|
| Name |
Divya |
| Address |
Department of anaesthesia Sgt medical college and hospital research institute near Budhera Gurugram Haryana 122505 |
| 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 Divya |
Sgt medical college and hospital |
Department of anaesthesia OT complex 1st floor Room no -2
Gurgaon
HARYANA |
9552315624
Divyaahlawat5400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Faculty of Medicine & Health Sciences, SGT university institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Dose 10 mL / min intravenously using infusion pump for minimum 3 minutes . |
| Intervention |
Phenylephrine infusion |
dose 100 mcg/min intravenously using infusion pump for minimum 3 minutes . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA GRADE 2 ,3 pregnant female undergoing lscs elective and emergency surgery |
|
| ExclusionCriteria |
| Details |
ASA grade 4 and above pregnant female undergoing lscs and with haemoglobin less than 4 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perfusion index, SpO2 and heart rate
the sensory level shall be assessed and thereafter the incidence of hypotension, need for vasopressors and the number of episodes of bradycardia will be recorded. |
Perfusion index, SpO2 and heart rate will be measured every 1 min and bp every 3 minutes till delivery of placenta . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| APGAR score of the baby |
at 0 and 1 minute |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/04/2024 |
| 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="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
|
This study is being conducted to assess and confirm the usefulness of perfusion index as a predictor of spinal hypotension in parturients undergoing lower segment caesarean section. Furthermore, by measuring PI preoperatively (value > 3.5) we can define patients at risk of developing post spinal hypotension and guide the use of prophylactic phenylephrine infusion in such patients. We also aim to study a control group in which perfusion index shall be used to determine the need of bolus rescue doses of phenylephrine and this can simultaneously determine the usefulness of either treatment methodology. |