Asana AdjustmentNCT05749978
Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia
A study testing Asana adjustment in people with Asana Adjustment, run by Zhuan Zhang at 1 site in China.
Trial summary
The prone position is a special position often used for spinal surgery. As a special position of general anesthesia, after induction of general anesthesia, severe hemodynamic fluctuations often occur when the supine position is changed to the prone position, which seriously affects the patient's circulatory and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asana Adjustment
- What is being tested?
- Asana adjustment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Dec 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prone spine surgery after general anesthesia is planned.
- Age 18~85 years old.
- ASA grade I or II.
- BMI18.3-30kg/m2
Who cannot join
- Unstable angina or myocardial infarction, coronary heart disease, congestive heart failure, structural heart disease, arrhythmia within 6 months;
- Increased intracranial pressure and central nervous system injury or disease;
- Severe hypertension
- Patients with other diseases affecting their own circulatory system.
- Have or have a history of severe mental disorders;
- Bleeding volume >600ml or intraoperative blood transfusion treatment.
- Severe liver and kidney insufficiency
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu
Zhuan Zhang, professor, +8615062791355 ext. +8615062791355, zhangzhuancg@163.com
About this study
The prone position is a special position often used for spinal surgery. As a special position of general anesthesia, after induction of general anesthesia, severe hemodynamic fluctuations often occur when the supine position is changed to the prone position, which seriously affects the patient's circulatory and respiratory functions.
- Conditions
- Asana Adjustment
- Being tested
- Asana adjustment
- Keywords
- Trendelenburg position, Prone Position, Hemodynamics, Intra-abdominal pressure, Cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asana adjustmentBehavioural
Adjust the operating table to 15° head height and foot low in advance. The patient is then slowly turned over from the transport table to the operating table and completed in the prone position. After the patient's hemodynamic stability is smooth, adjust the operating table to the level.
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg position | Experimental | Not described Receives: Behavioral: Asana adjustment |
| Procumbent | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood pressure
Hemodynamics
Measured: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
Changes in the level of Cardiac output
Cardiac output
Measured: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
Secondary outcomes (2)
Intra-abdominal pressure level
Intra-abdominal pressure
Measured: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
Vasoactive drugs
Vasoactive drug dosage
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Jan 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asana AdjustmentStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749978
- Sponsor's protocol ID
- 20230218
- Status last verified
- Jan 2023
- First submitted
- 18 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05749978
- Acronym / sponsor ID
- 20230218
- Conditions
- Asana Adjustment
- Keywords
- Trendelenburg position, Prone Position, Hemodynamics, Intra-abdominal pressure, Cardiac output
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Mar 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 prone position is a special position often used for spinal surgery. As a special position of general anesthesia, after induction of general anesthesia, severe hemodynamic fluctuations often occur when the supine position is changed to the prone position, which seriously affects the patient's circulatory and respiratory functions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg position | Experimental | Behavioral: Asana adjustment |
| Procumbent | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prone spine surgery after general anesthesia is planned.
- Age 18~85 years old.
- ASA grade I or II.
- BMI18.3-30kg/m2
Key exclusion criteria (7 listed)
- Unstable angina or myocardial infarction, coronary heart disease, congestive heart failure, structural heart disease, arrhythmia within 6 months;
- Increased intracranial pressure and central nervous system injury or disease;
- Severe hypertension
- Patients with other diseases affecting their own circulatory system.
- Have or have a history of severe mental disorders;
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 |
|---|---|---|
| Asana adjustmentAdjust the operating table to 15° head height and foot low in advance. The patient is then slowly turned over from the transport table to the operating table and completed in the prone position. After the patient's hemodynamic stability is smooth, adjust the operating table to the level. | Behavioural | Trendelenburg position |
Primary outcome
Change in Blood pressure
Time frame: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
Hemodynamics
Changes in the level of Cardiac output
Time frame: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
Cardiac output
2 secondary outcomes
Intra-abdominal pressure level
Time frame: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
Vasoactive drugs
Time frame: Intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asana adjustment in people with Asana Adjustment, run by Zhuan Zhang 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 4 inclusion and 7 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 1 Mar 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 Zhuan Zhang (+8615062791355, zhangzhuancg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood pressure (time frame: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position). The study lists 2 primary outcomes in all. 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 1 Mar 2023.