FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/064948 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Can perfusion index from pulse oximetry predict incidence of fall in blood pressure following spinal anaesthesia with Levobupivacaine 0.5%(heavy) in lower segment caesarean section ? 
Scientific Title of Study   Perfusion index from pulse oximetry as a predictor of incidence of hypotension following spinal anaesthesia with Levobupivacaine 0.5%(heavy) in lower segment caesarean section .  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daleena Nelson  
Designation  PG Resident -MD Anaesthesiology 
Affiliation  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College,Rajnandgaon,Chhattisgarh  
Address  Room No :418,4th Floor,Department of Anaesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College ,Rajnandgaon Chhattisgarh

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9894547569  
Fax    
Email  daleenanelson@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smriti Bandhu 
Designation  Associate Professor  
Affiliation  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College,Rajnandgaon,Chhattisgarh  
Address  Room No :418,4th Floor,Department of Anaesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College ,Rajnandgaon Chhattisgarh

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7000562486  
Fax    
Email  drsmriti19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Smriti Bandhu 
Designation  Associate Professor 
Affiliation  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College,Rajnandgaon,Chhattisgarh  
Address  Room No:418,4th Floor,Department of Anaesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College ,Rajnandgaon Chhattisgarh

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7000562486  
Fax    
Email  drsmriti19@gmail.com  
 
Source of Monetary or Material Support  
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial MedicalCollege,Rajnandgaon,Chhattisgarh  
 
Primary Sponsor  
Name  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical CollegeRajnandgaonChhattisgarh 
Address  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College,Pendri ,Rajnandgaon,Chhattisgarh Pin -491441 
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 Daleena Nelson  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College,Rajnandgaon   Room No :418,4th floor, Department of Anaesthesiology,Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College,Pendri,Rajnandgaon ,Chhattisgarh Pin-491441
Rajnandgaon
CHHATTISGARH 		 9894547569

daleenanelson@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BRLSABVM MEDICAL COLLEGE RAJNANDGAON   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Inclusion criteria includes :
1.18 - 40years age
2.Term pregnant patients
3.ASA II
4.Elective cases
5.Height :150-160cm 
 
ExclusionCriteria 
Details  1.Emergency cases
2.Antepartum haemorrhage
3.Postpartum haemorrhage
4.Endocrine diseases including GDM and thyroid disorders
5.Gestational hypertension/ PIH/ Preeclampsia
6.Cardiovascular or cerebrovascular disease
7.Morbid obesity with a BMI more than40
8.Gestational age less than 37 or more than 40 weeks
9.Contraindications to spinal anesthesia
10.Foetus with known congenital anomalie 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Baseline PI and its correlation with intraoperative SBP,DBP and MAP  SBP,DBP,MAP,Respiratory rate,SpO2,PI are noted at 0,2,3,5,7 ,10minutes and then every 5minutes till the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of other side effects  Till the end of surgery 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/04/2024 
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="3"
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  

STUDY TITLE: Perfusion index from pulseoximetry as a predictor of hypotension following spinal anaesthesia with levobupivacaine 0.5%(Heavy) in lower segment Caesarean section.


RATIONALE:  Can perfusion index(PI) be used as a factor for predicting intraoperative hypotension in Caesarean section patients?

 AIM:  To predict hypotension in patients induced with 0.5% levobupivacaine (heavy) based on their baseline perfusion index (PI) values measured preoperatively . 

OBJECTIVES: Prediction of hypotension in caesarean section under spinal anaesthesia using perfusion index.

 SETTING:  B.R.L.S.A.B.V.M Medical College, Rajnandgaon.


STUDY DESIGN : Prospective observational study

TIME FRAME : 3 months , Prospective Study starting from 01/04/2024 to 30/06/24

POPULATION/ PARTICIPANTS :Patients scheduled for elective Caesarean section at B.R.L.S.A.B.V.M. Medical College, Rajnandgaon.

SAMPLE SIZE: 120

METHODS: Studies have shown that baseline PI > 3.5 has high predictability for intraoperative hypotension in parturients undergoing elective caesarean section under spinal anesthesia with Bupivacaine 0.5% (Heavy) . Hence we are doing this study with Levobupivacaine 0.5 %(Heavy) to see correlation between baseline PI values and intraoperative hypotension in patients undergoing elective LSCS .  Parturients undergoing elective caesarean delivery under spinal anaesthesia with hyperbaric Levobupivacaine (0.5%) will be enrolled in the study . The correlation between baseline PI and degree of hypotension during LSCS under spinal anaesthesia will be observed .  Predictability of spinal anaesthesia induced hypotension during Caesarean delivery by baseline PI will be evaluated . 

OUTCOME MEASURES:

Outcome :Baseline PI and its correlation with intraoperative  SBP,DBP and MAP

STATISTICS 

Descriptive statistics will be analysed with SPSS version 20.0 software .continuous variables will be presented as mean +-SD.

●Categorical variables will be expressed as frequencies and percentages.

●The Pearson’s chi square test or the chi square test of association will be used to determine if there isa relationship between 2 categorical variables.Spearman/Pearson correlation will be used to determine correlation in case of continuous variables.A p value less than 0.5. Will be considered statistically significant.







 
Close