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CTRI Number  CTRI/2025/10/095970 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
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 find out if pulse oximeter values from both toes can predict drop in blood pressure during spinal anesthesia for cesarean delivery 
Scientific Title of Study   Prediction of incidence of spinal hypotension using perfusion index from pulse oximetry of right and left toes in LSCS patients- 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 Aswini Gandhimathi R 
Designation  Postgraduate resident- MD Anesthesiology 
Affiliation  Chettinad hospital and research institute 
Address  Second floor ICU 3,Department of Anesthesiology, Chettinad hospital and research institute, Chettinad health city, rajiv gandhi salai(OMR), Kelambakkam, Tamilnadu 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  9487568525  
Fax    
Email  aswinigandhimathi98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Merlin Shalini Ruth 
Designation  Professor 
Affiliation  Chettinad hospital and research institute 
Address  Second floor ICU -3,Department of Anesthesiology, Chettinad hospital and research institute, Chettinad health city, rajiv gandhi salai(OMR), Kelambakkam, Tamilnadu 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  9790983957  
Fax    
Email  merlin5shalini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aswini Gandhimathi R 
Designation  Postgraduate resident- MD Anesthesiology 
Affiliation  Chettinad hospital and research institute 
Address  Second floor ICU-3, Department of Anesthesiology, Chettinad hospital and research institute, Chettinad health city, rajiv gandhi salai(OMR), Kelambakkam, Tamilnadu 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  9487568525  
Fax    
Email  aswinigandhimathi98@gmail.com  
 
Source of Monetary or Material Support  
Chettinad hospital and research institute, chettinad health city, rajiv gandhi salai,kelambakkam,chennai,tamilnadu,india-603103  
 
Primary Sponsor  
Name  Dr Aswini Gandhimathi R 
Address  Second floor ICU-3, Chettinad hospital and research institute, chettinad health city, rajiv gandhi salai,kelambakkam,chennai,tamilnadu,india-603103 
Type of Sponsor  Other [This thesis is sponsored by myself] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aswini Gandhimathi R  Chettinad hospital and research institute  D-Block, first floor, Department of Anesthesiology, chettinad health city, rajiv gandhi salai, kelambakkam, chennai, tamilnadu,India-603103 Chennai TAMILNADU
Kancheepuram
TAMIL NADU 
09487568525

aswinigandhimathi98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committe For Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details 
Pregnant mothers with singleton fetus
Elective and Emergency LSCS
Patient Height- 150-180cm
American Society of Anesthesiologist(ASA) grade I,II

 
 
ExclusionCriteria 
Details  parturient age less than 18 years and more than 40 years
Body mass index more than 40
Parturient with placenta previa
Eclampsia and pre-eclampsia
cardiovascular or cerebrovascular disease
Peripheral vascular disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To predict the incidence of post spinal hypotension from toe perfusion index of lower segment cesarean section patients.  Baseline and post spinal anesthesia first 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To explore the correlation between toe Perfusion index and spinal hypotension and determine cut off value if any through ROC curves.
To assess the relationship between changes in the perfusion index in the right and left toe and incidence of post spinal hypotension
To analyse the differential perfusion index of upper limb and lower limb

 
Baseline and post spinal anesthesia first 30 minutes 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   05/11/2025 
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="6"
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   To Predict the incidence of spinal hypotension using  perfusion index from pulse oximetry of right and left toes in Lower segment cesarean section patients- A prospective Observational study

Primary objective:

 To predict the incidence of post spinal hypotension from toe perfusion index of lscs patients.

Secondary objective:

To explore the correlation between toe Perfusion index and spinal hypotension and determine cut off value if any through ROC curves.
To assess the relationship between changes in the perfusion index in the right and left toe and incidence of post spinal hypotension
To analyse the differential perfusion index of upper limb and lower limb 

             Inclusion criteria

 Age 18-40yrs
 Pregnant mothers with singleton fetus            
 Elective and Emergency LSCS                            
 Patient Height- 150 to180cm

Exclusion criteria
parturient age less than or equal to 18 years or more than or equal to 40 years
Body mass index more than 40
Parturient with placenta previa
Eclampsia and pre-eclampsia
cardiovascular or cerebrovascular disease
Peripheral vascular disease
Methodology:

After obtaining approval from Ethics committee. Informed and Written consent will be obtained from all patients .All patients will be instructed to fast  for  8 hours for solid diet prior to surgery. All patients will be pre medicated with Tablet Metaclopromide 10 mg  and Tab. Ranitidine 150 mg orally on the night before surgery and morning of surgery. Patients 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 patients will be coloaded with Lactated ringer’s(RL) solution of approximately 500 ml. Standard monitoring with electrocardiography, non invasive blood pressure, pulse oximetry with perfusion index will be performed as per ASA guidelines .Baseline BP, MAP, HR, SPO2, PERFUSION INDEX  will be monitored and noted. Pulse oximeter will be put on the left hand and right and left second toes of parturients in supine position for continuous monitoring of toe and hand perfusion index until the fetus is delivered .The perfusion index of upper limb and right and left toe will be noted 5mins before spinal anasthesia in supine position. Under sterile aseptic precautions all patients will receive subarachanoid block at L3-L4 or L4-L5, level with patients in sitting position using 25 or 26 G Quincke needleAfter cerebrospinal fluid is detected Inj 0.5% Bupivacaine(Hyperbaric)2ml with buprenorphine 0.2ml is administered.By use of a cold swab level of sensory block will be checked 5 min after spinal injection before starting surgery. Oxygen will be attached by use of face mask at 4 L/min to parturient after returned to supine position. After spinal anaesthesia, 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 3 min intervals till the delivery of baby.The perfusion index of left hand and right and left toe will be noted 5mins after spinal anesthesia in supine position. Decrease in Systolic blood pressure less than 20% from the baseline SBP will be characterized as hypotension .Hypotension will be treated with IV fluid (Ringer lactate/normal saline),if required vasopressors (Ephedrine, Phenylephrine, Noradrenaline. Any adverse effects like nausea, vomiting ,headache, bradycardia will be treated accordingly.

 

 



 
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