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CTRI Number  CTRI/2025/11/096956 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Understanding How a Person’s BMI Changes the Effects of Spinal Anesthesia 
Scientific Title of Study   Evaluation of the effect of Body Mass Index on the characteristics of spinal anaesthesia . 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Prasad 
Designation  Junior resident 
Affiliation  Jawahar lal nehru medical college  
Address  1,sahana plaza, shivabasava nagar belagavi
department of anaesthesiology , Dr.Prabhakar kore charitable hospital second floor
Belgaum
KARNATAKA
590010
India 
Phone  9741409512  
Fax    
Email  vyshnaviprasad99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana gogate  
Designation  professor  
Affiliation  Jawahar lal nehru medical college  
Address  department of anaesthesiology , Dr.Prabhakar kore charitable hospital second floor

Belgaum
KARNATAKA
590010
India 
Phone  9844083030  
Fax    
Email  vandanagogate@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vandana gogate  
Designation  professor  
Affiliation  Jawahar lal nehru medical college  
Address  department of anaesthesiology , Dr.Prabhakar kore charitable hospital second floor,free ot corridor

Belgaum
KARNATAKA
590010
India 
Phone  9844083030  
Fax    
Email  vandanagogate@gmail.com  
 
Source of Monetary or Material Support  
Jawhar Lal Nehru medical college Department of anaesthesiology Nehru Nagar Belagum , karnataka, India 590010 
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  Dr.Prabhakar kore charitable hospital, 2nd floor free ot corriodor nehru nagar, belagavi ,India 590010 
Type of Sponsor  Private 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 
DrVaishanvi prasad E  Dr.Prabhabkar kore Charitable Hospital   Department of anaesthesiology 2nd floor , Room 2 , free ot corridor Nehru Nagar, Belagavi
Belgaum
KARNATAKA 
9741409512

vyshnaviprasad99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  not applicable 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  spinal anesthesia drug - 0.5% Bupivacine heav  3ml of 0.5% bupvicaine heavy spinal anaesthesia through intra thecal route will be given to the patient after anaesthethic evaluvation. this group will be used as an comprative group 
Intervention  spinal anesthesia drug - 0.5% Bupivacine heavy   3ml of 0.5% bupvicaine heavy spinal anaesthesia through intra thecal route will be given to the patient after anaesthethic evaluvation. effects of bmi on characteristics of spinal anaesthesia will be assesed, 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade one and two
Age of the patient between eightneen to sixty years
Patient posted for elective surgery under spinal anaesthesia
BMI of the patient more than eightneen point five
Willing to provide informed consent
 
 
ExclusionCriteria 
Details  Patient refusal
ASA grade III or more
Patients who are on anticoagulant therapy
BMI of the patient less than 18.5
Known spinal deformities or neurological disorders
Pregnant patients
•Patients with contradications to spinal anaesthesia
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To detrmine the effect of body mass index on onset and duration of sensory and motor block spinal anaesthesia practice  ONSET OF SENSORY BLOCK
DURATION OF SENSORY BLOCK
ONSET OF MOTOR BLOCK
DURATION OF MOTOR BLOCK

0 minutes
5 minutes
10 minutes
15 minutes
20 minutes
25 minutes
30 minutes

 
 
Secondary Outcome  
Outcome  TimePoints 
To detrmine the effect of body mass index on onset & duration of sensory & motor block spinal anaesthesia practice  5 mins
10 mins
15 mins
20 mins
25 mins
30 mins  
 
Target Sample Size   Total Sample Size="61"
Sample Size from India="61" 
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)   24/11/2025 
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 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  

After the approval from the ethical committee and taking written consent from 61 patients who are undergoing elective surgery under spinal anaesthesia and who fulfilled inclusion and exclusion criteriawill be included for the surgery.Baseline data like age ,sex, height, weight and BMI of the patient will be recorded. Standard pre-anaesthetic assessment will be performed.For every patient transferred to the induction room , an intravenous line will be secured ,IV fluids started and standered ISA monitors attached

 

A 23 guage quinke needle will be inserted into the subarchnoid space at the L2-L3 level and 3ml of 0.5% bupivacaine heavy will be injected after confirmation of free flow of CSF. NIBP,SPO2 and heart rate will be recorded every five minutes for first thirty minutes and every ten minute till the end of the surgery. Cold swab test will be performed to assess the onset of sensory blockade and will be considered when T10 level is achieved and duration of sensory block will be determined by 2 segment regression. Modified bromage scale [0-Full movements of legs and feet 1-Inability to raise extended leg;able to move knees and feet 2-Inability to raise extended leg and move knee;able to move feet 3-Complete block of motor function in lower limbs ] will be used to assess the onset of motor block in the patient and duration of motor block will be assessed postoperatively and noted

 

 

 
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