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CTRI Number  CTRI/2024/08/071987 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Inferior Venacaval Collapsibility Index guided fluid preloading to prevent hypotension after Spinal Anesthesia  
Scientific Title of Study   Inferior Venacaval Collapsibility Index guided volume preload to prevent spinal hypotension in lower abdominal surgeries  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mustoor Manjeera 
Designation  Junior Resident 
Affiliation  Shri B M Patil Medical College, Hospital And Research Center, Vijayapura, Karnataka  
Address  3rd floor OT complex,Department of Anesthesiology Shri B M Patil Medical college, Hospital and Research Center, Solapur Road, Bangaramma Sajjan Campus, Vijayapura, KARNATAKA_ 586 103 India

Bijapur
KARNATAKA
586103
India 
Phone  8297539586  
Fax    
Email  manjeera.m.mm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nirmala Devi 
Designation  Associate Professor 
Affiliation  Shri B M Patil Medical college, Hospital and Research Center 
Address  3rd Floor Ot Complex, Department Of Anaesthesiology, Shri B M Patil Medical college ,Hospital and Research Centre, Solapur Road, Vijayapura. Bijapur KARNATAKA 586103 India

Bijapur
KARNATAKA
586103
India 
Phone  8217618954  
Fax    
Email  nirmalakagalkar77@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nirmala Devi 
Designation  Associate Professor 
Affiliation  Shri B M Patil Medical college, Hospital and Research Center 
Address  3rd Floor Ot Complex, Department Of Anaesthesiology, Shri B M Patil Medical college ,Hospital and Research Centre, Solapur Road, Vijayapura. Bijapur KARNATAKA 586103 India

Bijapur
KARNATAKA
586103
India 
Phone  8217618954  
Fax    
Email  nirmalakagalkar77@gmail.com  
 
Source of Monetary or Material Support  
Shri B.M.Patil Medical College Hospital And Research Centre,Vijayapura,Karnataka ,India 586103  
 
Primary Sponsor  
Name  Shri BM Patil Medical College Hospital And Research Centre 
Address  3rd Floor Ot Complex, Department Of Anaesthesiology, Solapur Road, Vijayapura,Karnataka,India 586103 
Type of Sponsor  Research institution and hospital 
 
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 Nirmala Devi  Shri B M Patil Medical College ,Hospital and Research Center  3rd Floor OT complex ,Department of Anaesthesiology, Shri B M Patil Medical college ,Hospital and Research Centre, Solapur Road, Vijayapura,Karnataka,In dia
Bijapur
KARNATAKA 		 8217618954

nirmalakagalkar77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BLDE(Deemed to be University) Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group (group c)  If IVCCI 43.5% he is into control group (group c) ● If IVCCI 43. 5% no preloading of fluid is done 
Intervention  fluid responder group (group p)  IVCCI 43.5% he is categorized as fluid responder group (group p) ● If The patients in fluid responder group are given a bolus fluid of 10ml/kg body weight over 15min preoperatively by investigator 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 20 to 65 years, patients of either sex, ASA 1 and 2, BMI less than 35kg/m2 
 
ExclusionCriteria 
Details  Pregnant women
➢ Patients with cardiovascular and pulmonary disorders
➢ Patients with Hepatic and Renal diseases.
➢ Patients on anticoagulants or coagulation disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison Of Effect Of Preload In Patients With IVCCI Greater Than 43.5% TO Prevent Spinal Hypotension With Patients Whose IVCCI Less Than 43.5% Without Preload  Intraoperatively After Giving Spinal Anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the total fluid consumption in both groups.
2) To calculate the dose of phenylephrine required to overcome hypotension .
3) To access other side effect of drugs like nausea and vomiting 		 Intraoperatively After Giving Spinal Anaesthesia 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   16/08/2024 
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="1"
Months="0"
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   This Study Is To Determine The Effect Of IVCCI-Guided Preloading Of Patients To Prevent Hypotension In Patients After Spinal Anaesthesia And Comparing The Dose Of Phenylephrine Used To Prevent Hypotension In Fluid Responder And Control Group 
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