Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

January 27, 2022 updated by: DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

Fluid management is a fundamental aspect of anesthesia. Several monitorization methods have been introduced to optimize fuid management.

To date neither of them were ideal. Corrected flow time measurement (FTc) in the carotid artery was recently introduced to detect fluid responsiveness.

Spinal anesthesia causes hypotension and fluid preloading is suggested to overcome this problem.

The aim of this study is to evaluate the effect of FTc guided fluid loading on spinal anesthesia induced hypotension.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomly allocated into 3 groups. Group C (Control) will receive spinal anesthesia after initiation of intravenous (iv) access without fluid preloading and will receive 2 ml/kg Ringer's lactate during anesthesia..

Group P (preloading) will receive 10 ml/kg Ringer's lactate before spinal block.

In Group FTc, ultrasonographic measurement of corrected flow time in carotid artery will be measured using 10-5 megahertz linear probe. On the two-dimensional image, the optimal image of the long-axis view will be obtained at the left common carotid artery. The sample volume will be placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination will be performed. Cardiac cycle time and carotid flow time will be measured. Carotid flow time will be measured between the upstroke of the flow tracing and the dicrotic notch, and it will be corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time).

The blood pressure will be measured 5 minutes before spinal anesthesia is commenced (baseline) and every minute afterwards until end of surgery.

Group FTc will receive a 500 mL Ringer's lactate bolus if the FTc is <349 ms (fluid responder); the FTc measurement will be repeated 15 minutes later and additional 500 mL Ringer's lactate bolus will be applied if the patient is still considered fluid responder; this sequence will be repeated until the patient's FTc is > 349 ms (non responder).

Ephedrine bolus will be used in allh groups if the mean arterial pressure drops below 30% of the baseline value.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Diskapi Yildirim Beyazit Teaching and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (19-80 years of age) who were scheduled to undergo arthroscopic knee surgery under spinal anesthesia

Exclusion Criteria:

  • Mean blood pressure < 70 mmHg before induction of general anesthesia
  • Patients who have currently taken angiotensin-converting enzyme inhibitor
  • Patients who have currently taken angiotensin receptor blocker
  • the presence of carotid artery stenosis > 50%
  • cardiac rhythm other than sinus
  • unstable angina
  • a left ventricular ejection fraction of < 40%
  • severe vascular disease
  • implanted pacemaker/cardioverter
  • autonomic nervous system disorders
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group Control
will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia
Other: Group Control 2 ml/kg "Ringer's lactate" Lafleks®
will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia
EXPERIMENTAL: Group Preloading
will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading
Other: Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®
will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading
EXPERIMENTAL: Group Carotis FTc
will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder
Other: Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®
will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Hypotension
Time Frame: 5 minutes after induction of spinal anesthesia
Mean arterial pressure >30% lower than baseline value
5 minutes after induction of spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients receiving Vasopressor therapy
Time Frame: 5 minutes after induction of spinal anesthesia
Ephedrine will be administered if mean arterial pressure drops >30% than baseline value
5 minutes after induction of spinal anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: Dilek Ünal, University of Health Sciences Dıskapı Yıldırım Beyazıt Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (ACTUAL)

November 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Spinal anesthesia-FTc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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