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Clinical Trials/CTRI/2025/07/090681
CTRI/2025/07/090681
Not yet recruiting
Phase 2

A comparitive study of fluid administration for prevention of spinal anaesthesia induced hypotension based IVC collapsibility index vs conventional method

ESIC Medical College and Hospital1 site in 1 country120 target enrollmentStarted: August 1, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
ESIC Medical College and Hospital
Enrollment
120
Locations
1
Primary Endpoint
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

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Patient refusal Patients having contraindications to spinal anaesthesia Known allergy to local anaesthetics coagulation disorders raised intracranial pressure infection at the site of injection.

Outcomes

Primary Outcomes

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

Time Frame: Every 3 min from 0 to 30 min after administration of spinal anaesthesia

Secondary Outcomes

  • 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)

Investigators

Sponsor
ESIC Medical College and Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Aparna V

ESIC Medical College and Hospital

Study Sites (1)

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