| CTRI Number |
CTRI/2025/07/090681 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intravenous Fluid Administration ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Methods of giving Intravenous Fluids to prevent Low blood pressure after Spinal Anaesthesia injection in adults undergoing lower abdominal surgery |
|
Scientific Title of Study
|
A comparitive study of fluid administration for prevention of spinal anaesthesia induced hypotension based IVC collapsibility index vs conventional method |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna V |
| Designation |
Post graduate |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
7397337180 |
| Fax |
|
| Email |
aparnavibooshnan123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ilango Ganeshan Prof Anaes |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078
Chennai
TAMIL NADU
60007i
India |
| Phone |
9884149429 |
| Fax |
|
| Email |
gilang@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Premkumar D |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9566220405 |
| Fax |
|
| Email |
doc.premkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078 |
| 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 |
| Aparna V |
Operation Theatre |
Anaesthesia department , B block 1st floor , ESIC Medical College and Hospital, Ashok Pillar main road , KK nagar , Chennai 600078
Chennai
TAMIL NADU |
7397337180
aparnavibooshnan123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Fluid Administration |
Conventional Fluid Administration at rate of 10ml/kg over 10mins as bolus. |
| Intervention |
IVC collapsibility Index based Fluid administration
|
Fluid Administration Based on IVC Collapsibility Index -( IVCCI Greater than 36% fluid will be administered till it becomes less than 36% over 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA physical status I and II
18-60 years of age of both the sexes
Patients undergoing infra umbilical surgeries with informed written consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients having contraindications to spinal anaesthesia
Known allergy to local anaesthetics
coagulation disorders
raised intracranial pressure
infection at the site of injection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the occurrence of spinal anaesthesia induced hypotension in initial 30 minutes following the administration of spinal anaesthesia between IVC collapsibility Index based fluid administration group vs conventional method of fluid administration group |
Every 3 min from 0 to 30 min after administration of spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate the average consumption of vasopressors INJ EPHIDREINE 5mg bolus & fluids RL between the two group |
Every 3min from 0 to 30 min after administration of spinal anaesthesia |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="10"
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 - NO
|
|
Brief Summary
|
A Prospective Double Blinded Randomise Controlled Study which includes patients undergoing infraumblical surgeries. they are divided into two groups . An Ultrasound guided IVC diameter and IVC Collapsibility Index will be performed in supine position by an experienced anaesthetist will be done . In Group A patients IVC collapsibility index will be measured , those patients with IVC collapsibility index greater than or equal to 36 percent will be administered with 500 ml of fluids over 5 min after which IVC collapsibility index will be measured again . If the collapsibility index remains greater than or equal to 36 percent again 500 ml of fluid will be administered over 5 min and IVC collapsibility index will be measured this procedure will be repeated until the collapsibility index becomes less than or equal to 36 percent. In group B patients , IVC collapsibility Index will be measured , a conventional method of fluid loading of 500ml will be administered irrespective of IVC collapsibility Index . Hemodynamic paramters including mean arterial pressure , systolic BP , diastolic BP , heart rate and requirement of vasopressors willl be recorded |