| 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
|
|
|
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
|
|
|
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
|