| CTRI Number |
CTRI/2025/08/092264 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying How Body Fat Affects Spinal Anaesthesia in Obese Patients undergoing lower abdominal surgery |
|
Scientific Title of Study
|
Comparison of effect of waist-hip-ratio with body mass index on level of subarachnoid block in obese patients undergoing infra-umbilical surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Kanwar |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi |
| Address |
Room NO 301 Third floor Department of anaesthesia
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi
Central
DELHI
110001
India |
| Phone |
8618978871 |
| Fax |
|
| Email |
nehashekhawat3110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Kachru |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi |
| Address |
Room NO 301 Third floor Department of anaesthesia
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi
Central
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Singh |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi |
| Address |
Room NO 301 Third floor Department of anaesthesia
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi
Central
DELHI
110001
India |
| Phone |
9910241887 |
| Fax |
|
| Email |
drjyoti.md@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr.Ram Manohar Lohia Hospital, Baba Kharak Singh Marg,Near Gurudwara Bangla Sahib New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr.Ram Manohar Lohia Hospital,New DelhiABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi |
| Address |
Department of Anaesthesia ABVIMS and Dr.RML Hospital,New Delhi 110001 |
| Type of Sponsor |
Government 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 |
| Neha Kanwar |
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi |
Room NO 301 Third floor Department of anaesthesia
ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi
Central
DELHI |
08618978871
nehashekhawat3110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI of more than 30kg/m2
Height between 150-175cms
surgeries of duration less than 2.5 hours |
|
| ExclusionCriteria |
| Details |
1)Refusal of consent for subarachnoid block
2)Patients with bleeding and coagulation disorders
3)Pregnant patients
4)Previous spinal surgeries
5)Spinal deformities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)Maximum level of sensory block achieved. |
To be seen after induction of spinal anaesthesia till 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Time taken to achieve maximum sensory block level as assessed by pin prick method.1
2) Time taken to achieve maximum motor blockade as assessed by modified Bromage scale.
3) Hemodynamic parameters (pulse rate, systolic blood pressure, diastolic blood pressure,mean arterial pressure, SpO2) will be recorded every two minutes for the first 30 minutes & then every ten minutes until the end of the procedure.
|
Time taken to achieve maximum sensory & motor blockade will be seen till 20 after induction of anaesthesia
Heamodynamic parameters will be assessed every two minutes for the first 10 minutes & then every 10 minutes until the end of the procedure.
|
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
15/08/2025 |
| 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="5"
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
|
In this study, we aim to understand whether the pattern of fat distribution in the body (measured using waist-to-hip ratio) or overall body weight (measured by BMI) has a greater influence on how high the effect of spinal anaesthesia spreads in obese patients undergoing lower abdominal (infra-umbilical) surgery.
Participants will undergo a routine pre-anaesthetic check-up. Their height, weight, waist and hip measurements will be taken. Spinal anaesthesia will be administered in a sitting position using a standard dose of bupivacaine and fentanyl. Monitoring will include ECG, blood pressure, and oxygen levels. The findings may help tailor anaesthesia practices in obese patients and improve safety and outcomes. |