Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

NCT ID: NCT03734497

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Meniscus Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomised
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group Control

will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia

Group Type ACTIVE_COMPARATOR

Group Control 2 ml/kg "Ringer's lactate" Lafleks®

Intervention Type OTHER

will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia

Group Preloading

will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading

Group Type EXPERIMENTAL

Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®

Intervention Type OTHER

will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading

Group Carotis FTc

will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder

Group Type EXPERIMENTAL

Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®

Intervention Type OTHER

will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder

Interventions

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Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®

will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder

Intervention Type OTHER

Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®

will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading

Intervention Type OTHER

Group Control 2 ml/kg "Ringer's lactate" Lafleks®

will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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DILEK YAZICIOGLU

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Ünal

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences Dıskapı Yıldırım Beyazıt Training and Research Hospital

Locations

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Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Dilek Ünal, Assoc.Prof.

Role: CONTACT

05336957855

References

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Lee JE, George RB, Habib AS. Spinal-induced hypotension: Incidence, mechanisms, prophylaxis, and management: Summarizing 20 years of research. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):57-68. doi: 10.1016/j.bpa.2017.01.001. Epub 2017 Jan 8.

Reference Type BACKGROUND
PMID: 28625306 (View on PubMed)

Song Y, Kwak YL, Song JW, Kim YJ, Shim JK. Respirophasic carotid artery peak velocity variation as a predictor of fluid responsiveness in mechanically ventilated patients with coronary artery disease. Br J Anaesth. 2014 Jul;113(1):61-6. doi: 10.1093/bja/aeu057. Epub 2014 Apr 9.

Reference Type RESULT
PMID: 24722322 (View on PubMed)

Ceruti S, Anselmi L, Minotti B, Franceschini D, Aguirre J, Borgeat A, Saporito A. Prevention of arterial hypotension after spinal anaesthesia using vena cava ultrasound to guide fluid management. Br J Anaesth. 2018 Jan;120(1):101-108. doi: 10.1016/j.bja.2017.08.001. Epub 2017 Nov 23.

Reference Type RESULT
PMID: 29397116 (View on PubMed)

Other Identifiers

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Spinal anesthesia-FTc

Identifier Type: -

Identifier Source: org_study_id

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