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Echocardiography Based Algorithm for Spinal Anaesthesia

NCT03106649 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-10

No results posted yet for this study

Summary

The main aim of the study is to compare the proposed algorithm for preventing and treating spinal hypotension with normal anesthesia management of a spinal anesthesia.

The proposed algorithm mainly will depend upon the left ventricular end diastolic area measurement by transthoracic echocardiography to assess the left ventricular preload status and its usefulness in preventing and treating spinal hypotension.

Conditions

Interventions

DEVICE

Echocardiography

Before administration of spinal anesthesia, Echocardiography will be performed to determine the LVEDA. If the LVEDA is more than 10 square cms, the patient will be considered as volume replete and spinal anesthesia will be administered. If the LVEDA is less than 10 square cms, a fluid bolus of 250 ml of a balanced salt solution will be given and LVEDA reassessed. This will be repeated till the LVEDA is more than 10 square cms or fluid bolus has been given twice and still the LVEDA is less than 10 square centimeters, in which case phenylephrine 1-2µg/kg will be given before administering spinal anesthesia.

DEVICE

Treatment of spinal hypotension

For treatment of spinal hypotension, in the event of hypotension(defined as a mean arterial pressure less than 60 mm Hg or decrease in mean arterial pressure of more than 20% from the baseline value) after spinal anesthesia, the LVEDA will be assessed. If more than 10 square centimeters, the patient will be considered volume replete and a vasopressor in the form of phenylephrine 1-2µg/kg will be given. If the LVEDA is less than 10 square centimeters, a volume bolus of 250ml will be given. On reassessment if the LVEDA is still less than 10 square centimeters the volume bolus can be repeated. In the event of hypotension persisting in spite of volume resuscitation, phenylephrine 1-2µg/kg will be given.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Sundara Kannan, MBBS · Post Graduate Institute of Medical Education and Research, Chandigarh

  • Bhupesh Kumar, MBBS,MD,DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-05-31
Completion
2017-06-30

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106649 on ClinicalTrials.gov