Hypotension on InductionNCT05891951
Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery
A study testing Fluid therapy under the guide of Carotid ultrasound in people with Hypotension on Induction, run by Min Su at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about Whether carotid ultrasound guided fluid management can reduce the incidence of hypotension after general anesthesia induction in elderly patients undergoing gastrointestinal surgery. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- Fluid therapy under the guide of Carotid ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Oct 2023
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-80 years old
- gender unlimited
- ASA: Grade I-Ⅲ
- BMI:18-30kg/㎡
- Patients undergoing elective gastrointestinal surgery under general anesthesia Informed consent
Who cannot join
- Carotid artery stenosis ≥50%
- Patients with heart valve disease
- Patients with left ventricular ejection fraction < 50%
- Patients with cardiac dysfunction (NYHA grade Ⅲ-Ⅳ and/or NTproBNP≥900pg/ml)
- Patients Combined with renal insufficiency (creatinine ≥178μmol/L, and/or blood urea nitrogen > 9mmol/L)
- Preoperative systolic blood pressure> 160mmHg or diastolic blood pressure > 100mmHg
- Refuse to participate in the test
- Patients participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
jingfeng Bai, master, +8615773490489, bjf159323@163.com
About this study
The goal of this clinical trial is to learn about Whether carotid ultrasound guided fluid management can reduce the incidence of hypotension after general anesthesia induction in elderly patients undergoing gastrointestinal surgery.
The main question[s] it aims to answer are:
Read more
Whether fluid therapy reduces the incidence of general anaesthesia induced hypotension in elderly patients undergoing gastrointestinal surgery.
Whether carotid ultrasound can guide fluid management in elderly patients undergoing gastrointestinal surgery.
Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. There is a comparison group: No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.
- Conditions
- Hypotension on Induction
- Being tested
- Fluid therapy under the guide of Carotid ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid therapy under the guide of Carotid ultrasoundOther
Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient. If volume is sufficient, no fluid therapy will be given.
| Study group | Role | What they receive |
|---|---|---|
| B-Carotid ultrasound guided fluid therapy | Experimental | Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. Receives: Other: Fluid therapy under the guide of Carotid ultrasound |
| C-No intervention | No intervention | No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of hypotension after anesthesia induction
Hypotension occurred from anesthesia induction to 20 minutes after induction in both groups.
Measured: General anesthesia induction from the beginning to 20 minutes after induction
Secondary outcomes (3)
Postoperative acute kidney injury
Postoperative creatinine increased for a short period of time to more than 0.3mg/dl (26.5μmol/L) or to more than 1.5 times the preoperative creatinine concentration.
Measured: Within 7 days after surgery
postoperative delirium
Newly diagnosed delirium by the psychiatric department within 30 days after surgery
Measured: Within 30 days after surgery
postoperative stroke
Any newly diagnosed postoperative neurological dysfunction within 30 days after surgery.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 May 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled clinical study to investigate whether carotid ultrasound-guided fluid therapy reduces the incidence of induced hypotension in elderly patients undergoing gastrointestinal surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Su Min, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891951
- Sponsor's protocol ID
- 2023197
- Status last verified
- Jun 2023
- First submitted
- 28 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT05891951
- Acronym / sponsor ID
- 2023197
- Conditions
- Hypotension on Induction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Min SuUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 7 Jun 2023 (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 goal of this clinical trial is to learn about Whether carotid ultrasound guided fluid management can reduce the incidence of hypotension after general anesthesia induction in elderly patients undergoing gastrointestinal surgery.
The main question[s] it aims to answer are:
Whether fluid therapy reduces the incidence of general anaesthesia induced hypotension in elderly patients undergoing gastrointestinal surgery.
Whether carotid ultrasound can guide fluid management in elderly patients undergoing gastrointestinal surgery.
Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. There is a comparison group: No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled clinical study to investigate whether carotid ultrasound-guided fluid therapy reduces the incidence of induced hypotension in elderly patients undergoing gastrointestinal surgery.
| Arm | Type | Receives |
|---|---|---|
| B-Carotid ultrasound guided fluid therapy | Experimental | Other: Fluid therapy under the guide of Carotid ultrasoundParticipants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. |
| C-No intervention | No intervention | –No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60-80 years old
- gender unlimited
- ASA: Grade I-Ⅲ
- BMI:18-30kg/㎡
- Patients undergoing elective gastrointestinal surgery under general anesthesia Informed consent
Key exclusion criteria (8 listed)
- Carotid artery stenosis ≥50%
- Patients with heart valve disease
- Patients with left ventricular ejection fraction < 50%
- Patients with cardiac dysfunction (NYHA grade Ⅲ-Ⅳ and/or NTproBNP≥900pg/ml)
- Patients Combined with renal insufficiency (creatinine ≥178μmol/L, and/or blood urea nitrogen > 9mmol/L)
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 |
|---|---|---|
| Fluid therapy under the guide of Carotid ultrasoundParticipants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient. If volume is sufficient, no fluid therapy will be given. | Other | B-Carotid ultrasound guided fluid therapy |
Primary outcome
Occurrence of hypotension after anesthesia induction
Time frame: General anesthesia induction from the beginning to 20 minutes after induction
Hypotension occurred from anesthesia induction to 20 minutes after induction in both groups.
3 secondary outcomes
Postoperative acute kidney injury
Time frame: Within 7 days after surgery
postoperative delirium
Time frame: Within 30 days after surgery
postoperative stroke
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Anesthesia
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.
Su Min study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid therapy under the guide of Carotid ultrasound in people with Hypotension on Induction, run by Min Su 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingfeng Bai (15773490489, bjf159323@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of hypotension after anesthesia induction (time frame: General anesthesia induction from the beginning to 20 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2023.