NCT03734497

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
3.6 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 5, 2026

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

November 1, 2018

Last Update Submit

February 3, 2026

Conditions

Meniscus Disorder

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Hypotension

    Mean arterial pressure \>30% lower than baseline value

    5 minutes after induction of spinal anesthesia

Secondary Outcomes (1)

  • Number of patients receiving Vasopressor therapy

    5 minutes after induction of spinal anesthesia

Study Arms (3)

Group Control

ACTIVE COMPARATOR

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

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

Group Preloading

EXPERIMENTAL

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

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

Group Carotis FTc

EXPERIMENTAL

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

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

Interventions

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

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

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

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

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

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

Group Carotis FTc

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28625306BACKGROUND

  • 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.

    PMID: 24722322RESULT

  • 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.

    PMID: 29397116RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Dilek Ünal

    University of Health Sciences Dıskapı Yıldırım Beyazıt Training and Research Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 8, 2018

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

February 5, 2026

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)