| CTRI Number |
CTRI/2022/09/045385 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
05/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
perfusion index as screening tool in caesarean section |
|
Scientific Title of Study
|
Evaluation of perfusion index as screening
tool for prediction of hypotension and shivering in caesarian section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARITA GANDHI |
| Designation |
resident |
| Affiliation |
GCS MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
GCS MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTRE
OPP DRM OFFICE
Ahmadabad
GUJARAT
380025
India |
| Phone |
9426785639 |
| Fax |
|
| Email |
parita288gandhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HEENA CHHANWAL |
| Designation |
Professor and Head |
| Affiliation |
GCS MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
GCS MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTRE
OPP DRM OFFICE
Ahmadabad
GUJARAT
380025
India |
| Phone |
9925497393 |
| Fax |
|
| Email |
drmrshc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PARITA GANDHI |
| Designation |
resident |
| Affiliation |
GCS MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
GCS MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTRE
OPP DRM OFFICE
Ahmadabad
GUJARAT
380025
India |
| Phone |
9426785639 |
| Fax |
|
| Email |
parita288gandhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
GCS Medical College Hospital and Research Centre |
| Address |
GCS Medical College Hospital and Research Centre, Opp DRM Office, Naroda Road |
| Type of Sponsor |
Research institution and hospital |
|
|
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 parita gandhi |
GCS Medical College Hospital and Research Centre, Opp DRM Office, Naroda Road |
Department of anaesthesia/Ground floor Main OT Complex
Ahmadabad
GUJARAT |
9426785639
parita288gandhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee gcs medical college |
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 |
perfusion index less than 3.5 |
We will record baseline perfusion index of patient
if less than 3.5 patient to be included in this group,spinal given and monitored for hypotension and shivering for 1 hour |
| Comparator Agent |
perfusion index more than 3.5 |
We will record baseline perfusion index of patient if more than 3.5 patient to be included in this group, spinal given and monitored for hypotension and shivering for 1 hour |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade II posted for
caesarean section
20-35 yrs female |
|
| ExclusionCriteria |
| Details |
unwilling to
participate/Refusing to
consent
Contraindication to Regional
Anesthesia
ASA grade III & IV
Caesarean section done
under General Anesthesia
Pre eclampsia & eclampsia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of baseline heart rate and MAP between two groups |
BASELINE, 1 MIN, 2 MIN, 5 MIN, 10 MIN,15 MIN, 30 MIN ,1 HOUR, 2 HOUR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grade of shivering after spinal anesthesia |
At BASELINE, 1 MIN, 2 MIN, 5 MIN, 10 MIN,15 MIN, 30 MIN ,1 HOUR, 2 HOUR after spinal anesthesia |
|
|
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)
|
10/09/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
ORIGINAL REASEARCH ARTICLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aims
The aim of this study was to determine whether a baseline PI can predict hypotension and shivering after spinal anesthesia for caesarean section.
Material & Methodology
We will record baseline perfusion index of patient
Then predict if according to that base value if there are chances of hypotension and shivering or not
If our prediction is true or false we will grade them as true positive , true negative , false positive and false negative.
Patients of ASA Grade I & II posted for caesarean section to be included & divided into two groups.
Benefit:
Preoperative perfusion index can predict post-anesthetic shivering in patients undergoing caesarean section with spinal anesthesia. |