Echocardiography Based Algorithm for Spinal Anaesthesia

NCT03106649 | Unknown

• 1 other identifier: 10306/PG-2Trg/2015/1696
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Hypotension

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  To compare an ECHO based algorithm of hemodynamic management as compared to standard practice in decreasing the incidence of post spinal hypotension (MAP \>20% of baseline or MAP \<60 mm Hg).

  30 minutes

Secondary Outcomes (5)

• number of episodes of hypotension.

  30 minutes

• magnitude of hypotension.

  30 minutes

• duration of hypotension.

  30 minutes

• use of IV fluids

  30 minutes

• use of vasopressors

  30 minutes

Study Arms (2)

Gr (E)

EXPERIMENTAL

The group in which the proposed algorithm for prevention and treatment of spinal hypotension will be tested with regard to fluid and vasopressor use, by means of echocardiography.

Device: Echocardiography; Device: Treatment of spinal hypotension

Gr (S)

NO INTERVENTION

The control group in which the anesthesia (fluid and vasopressor) management will be decided by the attending anesthesiologist

Interventions

Echocardiography DEVICE

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.

Gr (E)

Treatment of spinal hypotension DEVICE

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.

Gr (E)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- above 40 years of age presenting for elective lower abdominal or lower limb surgery and eligible to receive a subarachnoid block.

You may not qualify if:

• Patients with contraindications to a central neuraxial block such as pre- existing coagulopathy, local sepsis at site of insertion, ongoing hemodynamic instability (defined as systolic blood pressure\< 90 mm Hg or MAP\< 65mm Hg), unwillingness to undergo a regional anaesthesia, co- existing pregnancy, spinal dysraphism or, previous history of spinal instrumentation or surgery, chest deformity, demonstrated systolic dysfunction on screening echocardiography (defined as LVEF \<50% or, fractional shortening \< 25%), valvular heart disease (known or diagnosed on screening echo), chronic renal or liver disease and unwilling to participate in the trial.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160015, India

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Sundara Kannan, MBBS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Bhupesh Kumar, MBBS,MD,DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Central Study Contacts

Sundara Kannan, MBBS

CONTACT

8968603573; avsksundar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 10, 2017
• Study Start: April 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)