| CTRI Number |
CTRI/2022/04/041833 [Registered on: 12/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to predict hypotention during spinal anaesthesia in lower segment caesarean section by perfusion index |
|
Scientific Title of Study
|
PERFUSION INDEX AS AN EARLY PREDICTOR OF HYPOTENSION
DURING SPINAL ANAESTHESIA FOR LOWER SEGMENT
CAESAREAN SECTION - A RANDOMIZED DOUBLE BLIND
PROSPECTIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kapil singh |
| Designation |
post graduate student |
| Affiliation |
Institutional ethical committee,J.L.N. medical college Ajmer |
| Address |
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh
Ajmer
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
8386055613 |
| Fax |
|
| Email |
ksp5989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neena jain |
| Designation |
Senior professor |
| Affiliation |
Institutional ethical committee,J.L.N. medical college Ajmer |
| Address |
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh
Ajmer
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008666 |
| Fax |
|
| Email |
drneenaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neena jain |
| Designation |
Senior professor |
| Affiliation |
Institutional ethical committee,J.L.N. medical college Ajmer |
| Address |
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh
Ajmer
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008666 |
| Fax |
|
| Email |
drneenaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.L.N.Medical college, Ajmer, Rajasthan, India 305001 |
|
|
Primary Sponsor
|
| Name |
JLN Medical college hospital |
| Address |
J.L.N. Medical college & Hospital,Near bajrang
garh,Ajmer,Rajasthan-302021 |
| 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 Kapil singh |
Janana Hospital J.L.N. Medical college |
Depatt. of
anaesthesiology J.L.N.
Medical hospital,ajmer
Ajmer
RAJASTHAN |
8386055613
ksp5989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional ethical committee,J.L.N. medical college Ajmer |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant females (parturient) with gestational age of ≥ 32 weeks
Age between 25 – 40 years
American Society of Anesthesiologists (ASA) physical status I &II
To undergo Lower segment caesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Age < 25 years and >40 years
ASA grade III and above
Patients allergic to study drugs
Patients with contraindications to spinalanaesthesia.
Patient with history of cerebrovascular/cardiovascular disorder, preeclampsia,
placenta praevia, gestational diabetes, high risk pregnant women.
Patient refusal to take part in study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the incidence of hypotension |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the incidence of decrease in heart rate |
1 year |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
15/04/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of our study is to investigate the correlation between baseline perfusion index and haemodynamic changes in parturient undergoing lower segment caesarean section
under subarachnoid block.
OBJECTIVE: To compare the incidence of hypotension and decrease in heart rate in parturient with base line PI index >3.5 and ≤3.5.
|