| CTRI Number |
CTRI/2025/02/081190 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
STUDY TO COMPARE THE INCIDENCE OF SPINAL HYPOTENSION IN ELECTIVE LSCS CASES WITH PERFUSION INDEX IN PULSE OXIMETRY |
|
Scientific Title of Study
|
COMPARING THE INCIDENCE OF SPINAL HYPOTENSION IN ELECTIVE LSCS CASES
WITH DIFFERENT VALUES OF PERFUSION INDEX IN PULSE OXIMETRY –AN
OBSERVATIONAL PROSPECTIVE 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 |
DRMANIKANDANP |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Chettinad hospital and research institute |
| Address |
D block , 1st floor,Department of Anaesthesiology,Chettinad hospital
and research institute,chettinad health city,Rajiv Gandhi Salai( OMR)
,kelambakkam
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
8754604049 |
| Fax |
|
| Email |
drmani284396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr ASHOK KULASEKHAR |
| Designation |
Professor Head of the department |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Professor Head of the department, D- block 1st floor, Department of
Anaesthesiology, chettinad Hospital and Research Institute,
Chettinad Health city, Rajiv Gandhi salai, Kelambakkam
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
9840498420 |
| Fax |
|
| Email |
ashokk_dr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr ASHOK KULASEKHAR |
| Designation |
Professor Head of the department |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Professor Head of the department, D- block 1st floor, Department of
Anaesthesiology, chettinad Hospital and Research Institute,
Chettinad Health city, Rajiv Gandhi salai, Kelambakkam
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
9840498420 |
| Fax |
|
| Email |
ashokk_dr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chettinad hospital and Research Institute, Chettinad Health city, Rajiv Gandhi salai,
Kelambakkam, Chennai, Tamilnadu 603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad hospital and research insitute |
| Address |
Chettinad hospital and research institute, chettinad health city, Rajiv
Gandhi Salai,Kelambakkam, chennai, Tamilnadu, India-603103 |
| Type of Sponsor |
Private 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 |
| DRMANIKANDANP |
CHETTINAD HOSPITAL AND RESEARCH INSITUTE |
D- block , 1st floor,
Department of
Anaesthesiology,
Chettinad Health city,
Chettinad health
city,Rajiv Gandhi Salai,
Kelambakkam,,Chennai
,Tamilnadu
,India-603103
Chennai
TAMIL NADU |
8754604049
drmani284396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE ( CARE IHEC- I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV FLUIDS
PHENYLEPIHRINE |
Hypotension will be treated with IV
fluid (Ringer lactate solution-250ml bolus and then titrated according to Blood pressure ),if required vasopressors (Phenylepiphrine 50-100mcg and then according to blood pressure ) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Study participants with ASA Grade 2
Age group of the study participants 18-35 years
Pregnant mothers with singleton fetus
Elective LSCS
Patient Height-150-180CM
|
|
| ExclusionCriteria |
| Details |
ASA 3 and 4
patients with eclampsia and preeclampsia
patient with cardiovascualr disease
patient with eclampsia and pre eclmapsia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the association of post spinal hypotension in
elective LSCS in two groups with different perfusion index |
At baseline and till the end of surgery (120 mins ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the
use of vasopressors (Phenylepineprine)in number of patients in both group with spinal
hypotension
|
120 minutes |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Spinal anesthesia for lower segment cesarean section (LSCS) is one of the most common
procedures. Prediction of patients likely to develop hypotension will ensure effective
prevention and prompt management, which is of paramount importance for the best quality
care. • Various parameters have been studied to predict hypotension after spinal anesthesia but
a precise indicator was not established Parameter we will be using in this study is Perfusion
index from pulse oximetry Perfusion index (PI) is a non invasive, continuous, photo
plethysmographic pulse wave monitored from a pulse oximeter .It is defined as the ratio of
pulsatile blood flow to non pulsatile blood flow in peripheral vascular tissue and the value
ranges between 0.02% and 20% In parturients, at term, due to decreased peripheral vascular
tone, blood volume is pooled in the extremities, which increases further after sympathetic
blockade of spinal anesthesia resulting in hypotension. Parturients with high baseline PI are
expected to have lower peripheral vascular tone and hence are at higher risk of developing
hypotension following spinal anesthesiaAll the studies have used different baseline perfusion
index with varying results .I would like to use baseline perfusion index of 2.9and two groups
(Group 1 –PI < 2.9 and Group >2.9)which has increased sensitivity(83%) and specificity (96%)
according to the study - Harde MJ, Ranale PB, Fernandes S. Perfusion index to predict post
spinal hypotension in lower segment caesarean section. J Anaesthesiol Clin Pharmacol
2024;40:37-42.
Study Objectives
AIM Predicting spinal hypotension in elective LSCS cases using perfusion Index in pulse
oximetry
PRIMARY OBJECTIVE To Compare the association of post spinal hypotension in
elective LSCS in two groups with different perfusion index
SECONDARY OBJECTIVE To assess the
use of vasopressors (Phenylepineprine)in number of patients in both group with spinal
hypotension
Study design- AN OBSERVATIONAL PROSPECTIVE STUDY Number of subjects/sample size The sample size suggested for the present study is 30 in each group Group 1(PI < 2.9) -30
Participants Group 2(PI >2.9)-30 Participants
Study Methodology or procedure
Inclusion criteria Study participants with ASA Grade 2 Age group of the study participants 18-
35 years Pregnant mothers with singleton fetus Elective LSCS Patient Height-150-
180cm
Exclusion criteria Asa 3 and 4 Emergency cases Body mass index >40 Paturients with
placenta previa, Cardio and Cerebro vascular disease Preeclampsia and Eclampsia patients Peripheral vascular disease
After obtaining apporoval from Ethics comitee Informed and Written
consent Will be obtained from all patients All patients will be instructed to fast for 8 hrs for solid
diet prior to surgery All patients will be pre medicated with Tab.Metaclopromide 10 mg and Tab
Ranitidine 150 mg orally on the night before surgery and morning of surgery Patients baseline
pre operative vitals will be recorded ( HR, BP, MAP, SPO2 and perfusion index ) An intravenous
(IV) line will be established with an 18 G IV catheter in the dorsum of hand or wrist vein All the
patients are pre loaded with Lactated ringer’s(RL) solution of 10ml /kg(Approximately 500 ml) Standard monitoring with electrocardiography, non invasive blood pressure, pulse oximetry with
perfusion index will be performed as per ASA guidelines BP, MAP, HR, SPO2, PERFUSION INDEX
will be monitored Under sterile aseptic precautions all patients will receive sub arachanoid
block at L3-L4 or L4-L5, level with patients in sitting or lateral position using 25 or 26 G Quincke
needle After cerebrospinal fluid is detected Inj 0.5 Bupivacaine(Hyperbaric) 10mg with 60 mcg
of buprenorphine is administered Oxygen will be attached by use of face mask at 4 L/min to
parturient after returned to supine position. By use of a cold swab level of sensory block will be
checked 5 min after spinal injection before starting surgery. Heart rate (HR), Systolic blood
pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), perfusion index
(PI), saturation (SpO2) & respiratory rate(RR) will be recorded at 2 min intervals till the delivery
of baby & then 10 min intervals till the end of surgery after the SAB Decrease in Mean arterial
pressure (MAP) of <60 will characterized as hypotension Hypotension will be treated with IV
fluid (Ringer lactate solution),if required vasopressors (Phenylepiphrine ).Total amount of
vasopressors used will be noted Pearsons correlation will be used to asses correlation between
baseline Perfusion index and hypotension
Study outcome or end points - Compare the different values of perfusion index in pulse oximetry to predict spinal hypotension
in elective LSCS cases and prevent it effectively
Ethical Considerations- Approval from Chettinad Hospital and Research Institute IHEC (institutional human ethical
committee) will be obtained before starting the study. All participants will be informed regarding
the purpose of study, benefits, procedure and confidentiality of the research study in their local
language and in English. An informed and written consent will be taken from person who willing
to participate in study
Study Duration (in Months / Years)- 2 year References . Minal J. Harde, Prashant B. Ranale, Sarita Fernandes.Perfusion index to predict post spinal
hypotension in lower segment caesarean section DOI: 10.4103/joacp.joacp_178_22 Preoperative baseline peripheral perfusion index as an early predictor of the incidence of
hypotension following spinal anaesthesia in elective caesarean section. simi. p. babu , ashwini.
b , balasandhiya DOI: 10.47009/jamp.2024.6.2.72
study to evaluate perfusion index as a predictor of hypotension following spinal anesthesia
for caesarean section Jatin Lal, Teena Bansal, Shweta Bhardwaj, Mamta Jain, Anish Kumar Singh
DOI: 10.4103/joacp.JOACP_385_20
A study to evaluate perfusion index as a predictor of hypotension following spinal
anesthesia for caesarean section Jatin Lal, Teena Bansal, Shweta Bhardwaj, Mamta Jain, Anish
Kumar Singh DOI: 10.4103/joacp.JOACP_385_26 |