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CTRI Number  CTRI/2019/05/019030 [Registered on: 09/05/2019] Trial Registered Prospectively
Last Modified On: 07/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Using a finger pulse oximeter device reading to predict hypotension in lower segment cesarean section under spinal anaesthesia. 
Scientific Title of Study   Evaluation of perfusion index to predict hypotension in lower segment cesarean section under spinal anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abiral Nidhi 
Designation  Post Graduate Student (MD Anaesthesia) 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anaesthesia VMMC and Safdarjung Hospital

New Delhi
DELHI
110029
India 
Phone  00918130580279  
Fax    
Email  abiralnidhi@icloud.com  
 
Details of Contact Person
Scientific Query
 
Name  Poonam Gupta 
Designation  Consultant and Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care VMMC and Safdarjung Hospital

New Delhi
DELHI
110029
India 
Phone  00919818623450  
Fax    
Email  p.gupta182@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abiral Nidhi 
Designation  Post Graduate Student (MD Anaesthesia) 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anaesthesia VMMC and Safdarjung Hospital

New Delhi
DELHI
110029
India 
Phone  00918130580279  
Fax    
Email  abiralnidhi@icloud.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia VMMC and Safdarjung Hospital 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  VMMC and Safdarjung Hospital New Delhi - 110029 
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 
Abiral Nidhi  VMMC and Safdarjung Hospital  Department of Anaesthesia and Intensive Care
New Delhi
DELHI 
00918130580279

abiralnidhi@icloud.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VMMC and Safdarjung Hospital Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O742||Cardiac complications of anesthesia during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Parturients posted for cesarean section. 
 
ExclusionCriteria 
Details  Patients with placenta previa, preeclampsia, cardiovascular or cerebrovascular disease, gestational diabetes, body mass index ≥40, gestational age <36 or >41 weeks contraindications to spinal anaesthesia, those requiring additional oxytocic and/or additional surgical interventions, and those suffering from psychiatric illnesses and on treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perfusion Index more than 3.5 is associated with higher incidence of hypotension in lower segment cesarean section under spinal anaesthesia.  Baseline Perfusion Index and Intraoperative Blood Pressure measured after spinal anaesthesia till end of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters between the study groups, side effects after spinal anesthesia in elective lower segment cesarean section (e.g. nausea and vomiting) and the APGAR score, fetal pH and Base Excess (BE) in neonates born to parturients of the study groups.  Baseline and Intraoperatively 
 
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   N/A 
Date of First Enrollment (India)   14/05/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Sympathetic blockade and decreased cardiac output causes hypotension after spinal anaesthesia. Pregnancies are associated with increased sensitivity to local anaesthetic, decreased response to vasopressors and a low mean arterial pressure (MAP) at term. These women may develop profound hypotension following central neuraxial blockade for the lower segment caesarean section (LSCS).

The aim is to study the role of perfusion index to predict the incidence of hypotension in lower segment cesarean section under spinal anaesthesia. The primary objective of this study is to determine if Perfusion Index >3.5 is associated with higher incidence of hypotension in lower segment cesarean section under spinal anaesthesia.
Written informed consent will be taken from all patients followed by detailed pre-anaesthetic evaluation and airway examination. 

Patients will be received in the pre-operative room. The patient’s particulars will be checked. Standard monitoring with electrocardiography, automated NIBP, and pulse oximetry (SpO2) will be performed for baseline values and intraoperative monitoring. Baseline hemodynamic values including Perfusion Index will be recorded in the supine position. The perfusion index will be measured in the supine position using a specific pulse oximeter probe (Masimo® MightySat™Fingertip Pulse Oximeter; Masimo Corp., Irvine, CA, USA) attached to the left index finger of all patients to ensure uniformity in measured PI values. Those with a baseline Perfusion Index of ≤3.5 fall into Group I and those with a Perfusion Index of >3.5 fall into Group II. Maximum cephalad spread will be checked every 2 minutes from time of Subarachnoid Block (SAB) and then every minute till maximum level is achieved.). Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), SpO2 and PI will be recorded at 2 minutes intervals after the SAB up to 20 minutes and then at 5 minutes interval till the end of surgery. Hypotension is defined as a decrease in MAP <65 mmHg and treated with IV bolus of 6 mg injection Mephentermine. Bradycardia is defined as HR <55 beats/min and treated with injection atropine 0.6 mg IV bolus. Injection oxytocin (2 units IV bolus + 10 units in 500 ml of Ringer’s Lactate slow infusion over 1 hour) will be given as uterotonic following baby extraction. Patients requiring additional oxytocics and/or additional surgical interventions are excluded from

the study. The incidence of other side effects such as nausea, vomiting if observed will be recorded. Following extraction of the baby, APGAR score will be recorded at 1 and 5 minutes followed by fetal pH and base excess (BE) utilizing umbilical cord blood gas analysis where sample will be obtained from segment of double clamped cord after delivery of the baby in pre-heparinized 1 ml syringe.

All observations will be recorded in the proforma and analyzed using appropriate statistical methods.



 
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