FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071217 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To compare body mass index with abdominal circumference to height ratio to predict level of sensory block (main outcome) in participants undergoing caesarean section under exposure to anaesthesia. 
Scientific Title of Study   Comparison of body mass index with abdominal circumference to height ratio as a predictor of level of sensory block in patients undergoing caesarean section under sub arachnoid block. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abdullah Irfan Khan 
Designation  Post graduate resident 
Affiliation  Vardhman Mahavir Medical College ans Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari nagar, New Delhi

South
DELHI
110029
India 
Phone  8826548705  
Fax    
Email  irfan_abdullah52@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Parminder Singh Bhatia 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir Medical College ans Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari nagar, New Delhi

South
DELHI
110029
India 
Phone  7042142230  
Fax    
Email  psbhatia2@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Parminder Singh Bhatia 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir Medical College ans Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari nagar, New Delhi

South
DELHI
110029
India 
Phone  7042142230  
Fax    
Email  psbhatia2@rediffmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, 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 
Dr Abdullah Irfan Khan  Vardhman Mahavir medical college and Safdarjung hospital   Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
South
DELHI 		 8826548705

irfan_abdullah52@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir medical college and Safdarjung hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abdominal circumference to height ratio  Abdominal circumference and height will be measured for all patients undergoing caesarean section under sub arachnoid block, and abdominal circumference to height ratio will be calculated over a period of 18 months. 
Intervention  Body mass index   Weight and height will be measured for all patients undergoing caesarean section under sub arachnoid block, and body mass index will be calculated over a period of 18 months. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Elective caesarean cases.
Parturients between the ages 20-40 years.
American Society of Anaesthesiologists class 2 physical status. 
 
ExclusionCriteria 
Details  Contraindication to spinal anaesthesia.
Spine deformities. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare body mass index with abdominal circumference to height ratio as predictor of level of sensory block in patients undergoing caesarean section under subarachnoid block  Intraoperatively, level of block will be assessed at 1, 5, 10, 15, 20, and 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of hypotension
2. Use of vasopressors 		 Intraoperatively, blood pressure and other vital parameters will be assessed at 1, 3, 5 minutes and every 5 minutes thereafter 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3 
Date of First Enrollment (India)   15/08/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [irfan_abdullah52@hotmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 29-12-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a comparative study to compare body mass index with abdominal circumference to height ration as predictor of level of sensory block in patients undergoing Caesarean section under sub arachnoid block, with the hypothesis being that body mass index is a better predictor than abdominal circumference to height ratio of level of sensory block. Sub arachnoid block will be given in left lateral position with 1.8ml 0.5% hyperbaric bupivacaine(9mg) and 10mcg fentanyl. Primarily, the level of block will be recorded intra-operatively at 1, 5, 10, 15, 20, 30 minutes. Secondarily, the blood pressure and other hemodynamic parameters will be recorded at 1, 3, 5 minutes and every 5 minutes thereafter. 
Close