| CTRI Number |
CTRI/2023/08/056854 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utilising Perfusion Index to predict fall in blood pressure in pregnant patients with Pregnancy Induced Hypertension undergoing cesarean section under spinal anesthesia |
|
Scientific Title of Study
|
Evaluation of Perfusion Index for prediction of post spinal hypotension in parturients with Pregnancy Induced Hypertension undergoing Cesarean section - A Prospective observational 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 |
Dr Rudraraju Aravind |
| Designation |
resident anaesthesiologist |
| Affiliation |
ESI-PGIMSR,Basaidarapur |
| Address |
Room no:2207,Second floor OT,
OT complex,Dept of Anaesthesiology, ESI-PGIMSR,Basaidarapur, ring road, west delhi
West
DELHI
110015
India |
| Phone |
9550434755 |
| Fax |
|
| Email |
arvindfc007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil kumar thakur |
| Designation |
Professor and Head of Department |
| Affiliation |
employees state insurance corporation postgraduate institute of medical sciences and research |
| Address |
Room no:2210,Second floor OT, OT complex, Dept of Anaesthesiology,
ESI-PGIMSR,Basaidarapur, ring road, west delhi, 110015
West
DELHI
110015
India |
| Phone |
9350103337 |
| Fax |
|
| Email |
dranilthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rudraraju Aravind |
| Designation |
resident anaesthesiologist |
| Affiliation |
ESI PGIMSR |
| Address |
Room no-2207,Second floor OT,OT complex
Department of Anaesthesiology, ESIC-PGIMSR, Basaidarapur, Ring road, west delhi
West
DELHI
110015
India |
| Phone |
9550434755 |
| Fax |
|
| Email |
arvindfc007@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI post graduate institute of medical sciences and research new delhi |
|
|
Primary Sponsor
|
| Name |
ESI post graduate institute of medical sciences and research new delhi |
| Address |
Basaidarapur, Ring road new Delhi-110015 |
| 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 |
| DrAravind Rudraraju |
ESIC-PGIMSR |
Second Floor OT, OT complex,Department of Anaesthesia, ESIC-PGIMSR, Basaidarapur Ring Road, West Delhi
West
DELHI |
9550434755
arvindfc007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-Employees state insurance corporation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O134||Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating childbirth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists Grade 2 & 3
Parturients with PIH undergoing cesarean section under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Unstable hemodynamic status
parturients with severe pre eclampsia (BP >160/110)
Complicated obstetric history
Patients with placenta previa,gestational diabetes mellitus,Hypothyroidism,Hyperthyroidism
Parturients undergoing cesarean section under general anaesthesia
Multiple gestation
History of neurological,psychiatric,peripheral vascular disease,cardiac disease,chronic pain disorder
Parturients with nail paints |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the relation between perfusion index & blood pressure changes following spinal anaesthesia |
Point A: pre-operative room
Point B: 1 minute after spinal anaesthesia
Point C: 2 minutes after spinal anaesthesia
point D: 3 minutes after spinal anaesthesia
Point E: 4 minutes after spinal anaesthesia
Point F: 5 minutes after spinal anaesthesia
Point G: 7 minutes after spinal anaesthesia
Point H: 10 minutes after spinal anaesthesia
Point I: 15 minutes after spinal anaesthesia
Point J: 20 minutes after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/09/2023 |
| 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 - NO
|
|
Brief Summary
|
Aim is to assess the correlation of perfusion index as a predictor of Post spinal hypotension in parturients with PIH undergoing cesarean section.Total 104 patients will be enrolled for this study according to inclusion and exclusion criteria.
Study is Prospective Observational Non randomised study.
Written and informed consent will be taken.
Baseline Perfusion index,Blood pressure,Heart rate and oxygen saturation(spo2) will be measure in the pre-anaesthetic room.This will be time point A.
Parturient will be given spinal anaesthesia under all aseptic precautions with 25G quincke’s needle with 10 mg(2 ml) 0.5% (H) bupivacaine and patiets wiil be made to lie in a supine positon with 15 degrees left lateral tilt and values of perfusion index,Blood pressure,Heart rate and Oxygen saturation(spo2) will be measured at
Time point B: 1 minute after spinal anaesthesia
Time point C:2 minutes after spinal anaesthesia
Time point D:3 minutes after spinal anaesthesia
Time point E:4 minutes after spinal anaesthesia
Time point F:5 minutes after spinal anaesthesia
Time point G:7 minutes after spinal anaesthesia
Time point H:10 minutes after spinal anaesthesia
Time point I:15 minutes after spinal anaesthesia
Time point F:20 minutes after spinal anaesthesia
Primary Objective is to evaluate the predictability of perfusion index as an objective tool for post spinal hypotension in parturients with PIH undergoing cesarean section.
|