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CTRI Number  CTRI/2018/01/011360 [Registered on: 16/01/2018] Trial Registered Prospectively
Last Modified On: 16/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational 
Study Design  Single Arm Study 
Public Title of Study   Perfusion Index to identify hypotension 
Scientific Title of Study   Baseline perfusion Index as a predictor of hypotension following subarachnoid block in lower segment cesaerean 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 Steffi 
Designation  Post graduate student 
Affiliation  kanyakumari government medical college hospital 
Address  Department of Anaesthesiology Kanyakumari government medical college hospital asaripallam

Kanniyakumari
TAMIL NADU
629210
India 
Phone  9600298127  
Fax    
Email  steffij9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Edward Johnson 
Designation  Guide 
Affiliation  kanyakumari government medical college hospital 
Address  Department of Anaesthesiology Kanyakumari government medical college hospital asaripallam

Kanniyakumari
TAMIL NADU
629201
India 
Phone  9600298127  
Fax    
Email  edwardjohnson2310@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Steffi 
Designation  Post graduate student 
Affiliation  kanyakumari government medical college hospital 
Address  Department of Anaesthesiology Kanniyakumari government medical college hospital asaripallam

Kanniyakumari
TAMIL NADU
629201
India 
Phone    
Fax    
Email  steffij9@gmail.com  
 
Source of Monetary or Material Support  
Head of the department, Department of Anaesthesiology Kanyakumari govt medical college hospital, Asaripallam  
 
Primary Sponsor  
Name  Head of the Department 
Address  Department of Anaesthesiology Kanyakumari Govt medical college hospital, Asaripallam 
Type of Sponsor  Government medical college 
 
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 Steffi  Kanyakumari government medical college hospital  Department of Anaesthesiology Kanniyakumari government medical college hospital Asaripallam
Kanniyakumari
TAMIL NADU 		 9600298127

steffij9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, kanyakumari government medical college hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Antenatal patient undergoing caeserean section,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Perfusion Index  Baseline Perfusion index in LSCS patients under subarachnoid block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 ASA II
2 Elective caeserean section 
 
ExclusionCriteria 
Details  1 Patient refusal
2 ASA III and IV
3 Placenta previa
4 Preeclampsia
5 cardiovascular or cerebrovascular disease
6 BMI≥40
7 Overdistended uterus,twin pregnancy
8 Level of blockade T4
9 Patients requiring additional oxytocin or
additional surgical intervention

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence Hypotension  from first minute after spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1 Total doses of vasopressor required
2 Incidence of bradycardia 		 From first minute of spinal anaesthesia  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/01/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Aim: this study aims at investigating the correlation between baseline perfusion index and incidence of hypotension following subarachnoid block in LSCS patients

Methodology: Prospective observational study. The perfusion Index is measured in supine position is in  pulseoximeter probe after spinal anaesthesia in elective caeserean patient

Parameters: preop baseline values of blood pressure is noted  with primary outcome for incidence of hypotension & secondary outcome total vasopressor required to correct hypotension & incidence of bradycardia were recorded



 
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