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Clinical Trials/CTRI/2023/08/056048
CTRI/2023/08/056048Not yet recruitingPhase 4

Comparison of pre-operative ultrasonographic assessment of Inferior Vena Cava Collapsibility Index and Caval Aortic Index in predicting post spinal hypotension during elective surgeries

Maulana Azad Medical College1 site in 1 country90 target enrollmentStarted: October 8, 2023Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
90
Locations
1
Primary Endpoint
To compare IVCCI AND IVC:AO index in predicting the incidence of post spinal anaesthesia hypotension
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

WE ARE COMPARING THE PREOPERATIVE ULTRASONOGRAPHIC ASSESSMENT OF INFERIOR VENA CAVA COLLAPSIBILITY INDEX AND CAVAL AORTIC INDEX IN THE PREDICTION OF POST SPINAL HYPOTENSION IN PATIENTS UNDERGOING ELECTIVE SURGERIES BETWEEN THE AGE GROUP OF 18 T0 65 YEARS. THE AIM OF OUR STUDY IS TO COMPARE THE PREOPERATIVE ULTRASONOGRAPHIC ASSESSMENT OF INFERIOR VENA CAVA COLLAPSIBILITY INDEX AND CAVAL AORTIC INDEX IN PREDICTING THE POST SPINAL HYPOTENSION, TAKING A TOTAL SAMPLE SIZE OF 90, WITH 30 SAMPLES EACH IN THREE GROUPS

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •American Society of Anaesthesiology physical health status 1 and 2.

Exclusion Criteria

  • •Pregnant patients
  • •BMI more than 30kg/m2
  • •Absolute and relative contraindications for spinal anaesthesia
  • •Baseline arterial SBP <90mmhg OR MAP<65mmhg.

Outcomes

Primary Outcomes

To compare IVCCI AND IVC:AO index in predicting the incidence of post spinal anaesthesia hypotension

Time Frame: First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval

Secondary Outcomes

  • To compare the IVCCI & IVC:AO index with the total volume of fluid given during surgery(First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval)
  • To compare the number of hypotensive episodes occuring in a patient during surgery(First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval)
  • To evaluate & compare the requirement & total dose of vasopressors used during the surgery(First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval)
  • To compare the IVCCI & IVC:AO index with the volume of intravenous fluid infused before administering spinal anaesthesia(First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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