General Anesthesia Induction for Elective SurgeryNCT05628051
Carotid Artery Corrected Flow Time as a Predictor of Hypotension After Induction of General Anesthesia in Elderly Patients
An observational study of General Anesthesia Induction for Elective Surgery, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
The number of elderly patients undergoing elective surgery has been growing in recent years. Elderly patients often have a variety of underlying diseases, including hypertension, coronary heart disease, diabetes, arteriosclerosis, etc., which increase the risk. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- General Anesthesia Induction for Elective Surgery
- What is being tested?
- ultrasonographic measurement of carotid artery corrected flow time (FTc)
- Type of treatment
- Surgery or procedure
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Mar 2023
- Phase
- Observational
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who were scheduled to undergo elective surgery under general anesthesia
Who may be able to join
- patients who received elective surgery under general anesthesia, aged 65-85 years old, gender unlimited, ASAI-II
Who cannot join
- uncontrolled hypertension
- unstable angina pectoris
- history of myocardial infarction
- after heart stent implantation
- severe arrhythmia：Atrial fibrillation、Ventricular premature beat, frequent atrial premature beat, other non-sinus rhythm
- pacemaker implants
Show all 10Show fewer
- cardiomyopathy
- a left ventricular ejection fraction of < 40%
- history of neck trauma and surgery
- BMI>30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Carotid Corrected Flow Time Combined With Perioperative Fluid Therapy on Preventing Hypotension After General Anesthesia Induction in Elderly Patients
The number of elderly patients undergoing elective surgery has been growing in recent years. Elderly patients often have a variety of underlying diseases, including hypertension, coronary heart disease, diabetes, arteriosclerosis, etc., which increase the risk. When the elderly receive general anesthesia, hypotension often occurs after anesthesia induction. Once hypotension occurs, it may lead to myocardial ischemia, myocardial infarction, stroke and other serious complications. Therefore, in clinical anesthesia, a simple, quick and accurate prediction method is needed to evaluate and predict the risk of hypotension in elderly patients after induction, so that appropriate intervention measures can be taken in advance to reduce the incidence of hypotension in elderly patients after induction, thus reducing the occurrence of related complications and ensuring the safety of anesthesia and surgery.Carotid Artery Corrected Flow Time（FTc） is a recently developed volumetric predictor, which refers to the time between the the onset of systolic flow until the closure of the aortic valve. It is related to cardiac preload and can reflect cardiac output to a certain extent. It is considered as a reliable indicator for evaluating volume status and volumetric reactivity. Therefore, this study assessed the effect of FTc combined with perioperative fluid therapy on preventing hypotension after general anesthesia induction in elderly patients.
- Being tested
- ultrasonographic measurement of carotid artery corrected flow time (FTc)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic measurement of carotid artery corrected flow time (FTc)Procedure or surgery
Ultrasonic measurement of carotid corrected blood flow time: 1. Patient's head turned to the left 30°. Firstly, the 6.0 ~ 13.0MHz linear probe was placed longitudinally on the maternal neck, and the probe marker was oriented towards the maternal head. Real-time B-ultrasound images of the long axis of the right common carotid artery were obtained from the lower margin of the thyroid cartilage. Then, the probe was placed in the center of the carotid lumen, about 2cm from the bifurcation of the carotid artery, to obtain the arterial pulse Doppler flow spectrum and store the carotid flow waveform. 2. Using the caliper function of the ultrasonic instrument, carotid flow time (FT) was obtained by measuring the interval between the systolic ascending stage and the restroke notch. Wodey (W) formula to calculate FTc. FTc= FT+[1.29× (HR-60)
| Study group | Role | What they receive |
|---|---|---|
| Hypotension after anesthetic induction group | Patients with hypotension after anesthetic induction Receives: Procedure: ultrasonographic measurement of carotid artery corrected flow time (FTc) | |
| Non-hypotension after anesthetic induction group | Patients without hypotension after anesthetic induction Receives: Procedure: ultrasonographic measurement of carotid artery corrected flow time (FTc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid artery corrected flow time (FTc)
the area under the receiver operating characteristics curve of corrected flow time in carotid artery measured by ultrasonography to predict hypotension after anesthetic induction
Measured: 5 minutes before induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Jun 2022
- Primary completion30 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General Anesthesia Induction for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628051
- Sponsor's protocol ID
- 2022XHYG0018-01
- Status last verified
- Oct 2023
- First submitted
- 17 Nov 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang S, Liao Z, Chen A, Wang J, Xu X, Zhang L. Effect of carotid corrected flow time combined with perioperative fluid therapy on preventing hypotension after general anesthesia induction in elderly patients: a prospective cohort study. Int J Surg. 2024 Feb 1;110(2):799-809. doi: 10.1097/JS9.0000000000000863.
PubMed 37983823
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carotid Corrected Flow Time Combined With Perioperative Fluid Therapy on Preventing Hypotension After General Anesthesia Induction in Elderly Patients
- ClinicalTrials.gov ID
- NCT05628051
- Acronym / sponsor ID
- 2022XHYG0018-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 28 Nov 2022 (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.
The number of elderly patients undergoing elective surgery has been growing in recent years. Elderly patients often have a variety of underlying diseases, including hypertension, coronary heart disease, diabetes, arteriosclerosis, etc., which increase the risk. When the elderly receive general anesthesia, hypotension often occurs after anesthesia induction. Once hypotension occurs, it may lead to myocardial ischemia, myocardial infarction, stroke and other serious complications. Therefore, in clinical anesthesia, a simple, quick and accurate prediction method is needed to evaluate and predict the risk of hypotension in elderly patients after induction, so that appropriate intervention measures can be taken in advance to reduce the incidence of hypotension in elderly patients after induction, thus reducing the occurrence of related complications and ensuring the safety of anesthesia and surgery.Carotid Artery Corrected Flow Time（FTc） is a recently developed volumetric predictor, which refers to the time between the the onset of systolic flow until the closure of the aortic valve. It is related to cardiac preload and can reflect cardiac output to a certain extent. It is considered as a reliable indicator for evaluating volume status and volumetric reactivity. Therefore, this study assessed the effect of FTc combined with perioperative fluid therapy on preventing hypotension after general anesthesia induction in elderly patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotension after anesthetic induction group | – | Procedure: ultrasonographic measurement of carotid artery corrected flow time (FTc)Patients with hypotension after anesthetic induction |
| Non-hypotension after anesthetic induction group | – | Procedure: ultrasonographic measurement of carotid artery corrected flow time (FTc)Patients without hypotension after anesthetic induction |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who were scheduled to undergo elective surgery under general anesthesia
Key inclusion criteria (1 listed)
- patients who received elective surgery under general anesthesia, aged 65-85 years old, gender unlimited, ASAI-II
Key exclusion criteria (10 listed)
- uncontrolled hypertension
- unstable angina pectoris
- history of myocardial infarction
- after heart stent implantation
- severe arrhythmia：Atrial fibrillation、Ventricular premature beat, frequent atrial premature beat, other non-sinus rhythm
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 |
|---|---|---|
| ultrasonographic measurement of carotid artery corrected flow time (FTc)Ultrasonic measurement of carotid corrected blood flow time: 1. Patient's head turned to the left 30°. Firstly, the 6.0 ~ 13.0MHz linear probe was placed longitudinally on the maternal neck, and the probe marker was oriented towards the maternal head. Real-time B-ultrasound images of the long axis of the right common carotid artery were obtained from the lower margin of the thyroid cartilage. Then, the probe was placed in the center of the carotid lumen, about 2cm from the bifurcation of the carotid artery, to obtain the arterial pulse Doppler flow spectrum and store the carotid flow waveform. 2. Using the caliper function of the ultrasonic instrument, carotid flow time (FT) was obtained by measuring the interval between the systolic ascending stage and the restroke notch. Wodey (W) formula to calculate FTc. FTc= FT+[1.29× (HR-60) | Procedure or surgery | Hypotension after anesthetic induction group, Non-hypotension after anesthetic induction group |
Primary outcome
Carotid artery corrected flow time (FTc)
Time frame: 5 minutes before induction of general anesthesia
the area under the receiver operating characteristics curve of corrected flow time in carotid artery measured by ultrasonography to predict hypotension after anesthetic induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 37983823Huang S, Liao Z, Chen A, Wang J, Xu X, Zhang L. Effect of carotid corrected flow time combined with perioperative fluid therapy on preventing hypotension after general anesthesia induction in elderly patients: a prospective cohort study. Int J Surg. 2024 Feb 1;110(2):799-809. doi: 10.1097/JS9.0000000000000863.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia Induction for Elective Surgery, run by Fujian Medical University Union Hospital at 1 site in China.
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 10 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: finished, as of the sponsor's last update on 1 Nov 2023. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Carotid artery corrected flow time (FTc) (time frame: 5 minutes before induction of general 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 NCT05628051, which also lists 1 linked publication.
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 1 Nov 2023.