Meniscus DisorderNCT03734497
Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia
A study testing Group Carotis FTc 500 ml "Ringer's lactate" Lafleks® and Group Preloading 10 ml/kg "Ringer's lactate" Lafleks® in people with Meniscus Disorder, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Meniscus Disorder
- What is being tested?
- Group Carotis FTc 500 ml "Ringer's lactate" Lafleks® and Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (19-80 years of age) who were scheduled to undergo arthroscopic knee surgery under spinal anesthesia
Who cannot join
- 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
Show all 11Show fewer
- a left ventricular ejection fraction of < 40%
- severe vascular disease
- implanted pacemaker/cardioverter
- autonomic nervous system disorders
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, 06110
About this study
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.
Read the 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.
- Conditions
- Meniscus Disorder
- Being tested
- Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®, Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®, Group Control 2 ml/kg "Ringer's lactate" Lafleks®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 Preloading 10 ml/kg "Ringer's lactate" Lafleks®Other
will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading
Group Control 2 ml/kg "Ringer's lactate" Lafleks®Other
will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Control | Active comparator | will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia Receives: Other: Group Control 2 ml/kg "Ringer's lactate" Lafleks® |
| Group Preloading | Experimental | will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading Receives: 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 Receives: Other: Group Carotis FTc 500 ml "Ringer's lactate" Lafleks® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Hypotension
Mean arterial pressure >30% lower than baseline value
Measured: 5 minutes after induction of spinal anesthesia
Secondary outcomes (1)
Number of patients receiving Vasopressor therapy
Ephedrine will be administered if mean arterial pressure drops >30% than baseline value
Measured: 5 minutes after induction of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study startJul 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Ethical approval not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meniscus DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek Ünal, Principal investigator, University of Health Sciences Dıskapı Yıldırım Beyazıt Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734497
- Sponsor's protocol ID
- Spinal anesthesia-FTc
- Status last verified
- Sep 2021
- First submitted
- 1 Nov 2018
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28625306Song 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.
PubMed 24722322Ceruti 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.
PubMed 29397116
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03734497
- Acronym / sponsor ID
- Spinal anesthesia-FTc
- Conditions
- Meniscus Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethical approval not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective randomised
| Arm | Type | Receives |
|---|---|---|
| Group Control | Active comparator | Other: Group Control 2 ml/kg "Ringer's lactate" Lafleks®will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia |
| Group Preloading | Experimental | Other: Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading |
| Group Carotis FTc | Experimental | Other: Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (19-80 years of age) who were scheduled to undergo arthroscopic knee surgery under spinal anesthesia
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder | Other | Group Carotis FTc |
| Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading | Other | Group Preloading |
| Group Control 2 ml/kg "Ringer's lactate" Lafleks®will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia | Other | Group Control |
Primary outcome
Number of patients with Hypotension
Time frame: 5 minutes after induction of spinal anesthesia
Mean arterial pressure >30% lower than baseline value
1 secondary outcome
Number of patients receiving Vasopressor therapy
Time frame: 5 minutes after induction of spinal anesthesia
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 28625306Lee 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.
- Results publication: PubMed 24722322Song 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.
- Results publication: PubMed 29397116Ceruti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Ünal principal investigator
University of Health Sciences Dıskapı Yıldırım Beyazıt Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Carotis FTc 500 ml "Ringer's lactate" Lafleks® and Group Preloading 10 ml/kg "Ringer's lactate" Lafleks® in people with Meniscus Disorder, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Hypotension (time frame: 5 minutes after induction of spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734497, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.