| CTRI Number |
CTRI/2025/11/098048 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Fasting time and low blood pressure during anaesthesia in adults an observational study |
|
Scientific Title of Study
|
Effect of preoperative fasting duration on incidence of hypotension during spinal anaesthesia in adults - observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohananprasad |
| Designation |
PG scholar |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India
Chennai
TAMIL NADU
603203
India |
| Phone |
8925251189 |
| Fax |
|
| Email |
mohananprasad27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aravindhan K Y |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No D4-26,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603203
India |
| Phone |
8940068386 |
| Fax |
|
| Email |
aravindk3@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohananaprasad |
| Designation |
PG scholar |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603203
India |
| Phone |
8925251189 |
| Fax |
|
| Email |
mohananprasad27@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
SRM medical college Hospital and Research Centre, SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR ARAVINDHAN |
SRM medical college Hospital |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India
Chennai
TAMIL NADU |
8940068386
aravindk3@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 years to 60 years
2.Scheduled for elective surgical procedures under spinal anaesthesia
3.Classified as ASA physical status Class I, II, or III
|
|
| ExclusionCriteria |
| Details |
1.Patients with psychiatric illness.
2.Refusal to give consent for participation in the study
3.Emergency surgeries
4.Delayed gastric emptying
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether prolonged preoperative fasting duration is associated with an increased incidence of hypotension following spinal anaesthesia in adult surgical patients |
Each patient’s fasting duration will be recorded before surgery and they will be grouped as Group A (6 hours), Group B (6–8 hours), or Group C (greater than 8 hours) and In intraoperative MAP will be recorded at time period of preoperatively, zeroth minute of spinal anesthesia , 2 minute time of spinal anesthesia, 5th minute of spinal anesthesia, 15th minute of spinal anesthesia and 30th minutes time of spinal anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
22/12/2025 |
| 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="0"
Months="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mohananprasad27@gmail.com].
- For how long will this data be available start date provided 21-10-2026 and end date provided 21-07-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This prospective observational study evaluates whether the duration of preoperative fasting influences the incidence of hypotension in adults undergoing spinal anaesthesia for elective surgeries. A total of 120 patients will be classified based on fasting hours. Blood pressure changes after spinal anaesthesia will be assessed to determine the association between fasting duration and hypotension. The findings may help optimize fasting guidelines and improve perioperative patient safety |