HypotensionNCT03408301
The Status of Autonomic Tone Before Tourniquet Deflation During Total Knee Replacement
An observational study of Hypotension and Blood Pressure, Low, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
This study evaluates the influences of the status of sympathovagal balance before tourniquet deflation on a decrease in arterial blood pressure following the deflation during total knee replacement arthroplasty Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hypotension, Blood Pressure, Low
- What is being tested?
- Tourniquet deflation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jan 2014to 30 Jul 2014
- 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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing total knee replacement arthroplasty in a tertiary university hospital
Who may be able to join
- American Society of Anesthesiologists physical status I - II
- Body mass index < 35 kg/m2
Who cannot join
- Coagulation deficiencies
- Known allergies to local anesthetics
- Neurologic deficit on the side being operated on
- Inflammation at the lumbar puncture site
- Cardiac conduction disorders or arrhythmias
- Congestive heart failure
Show all 14Show fewer
- Serum electrolyte abnormalities
- Psychiatric disorders
- Patient's refusal
- Difficulty communicating with medical personnel
- Severe hypovolemia
- Increased intracranial pressure
- Severe aortic stenosis
- Severe mitral stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Sympathovagal Balance Before Tourniquet Deflation on a Decrease in Arterial Blood Pressure Following the Deflation During Total Knee Replacement Arthroplasty
This study evaluates the influences of the status of sympathovagal balance before tourniquet deflation on a decrease in arterial blood pressure following the deflation during total knee replacement arthroplasty
Read the detailed description
Patients present with different hemodynamic profiles after intraoperative tourniquet deflation during total knee replacement arthroplasty.
Sympathovagal balance can be measured before tourniquet deflation and might determine the hemodynamic response to tourniquet deflation.
- Conditions
- Hypotension, Blood Pressure, Low
- Being tested
- Tourniquet deflation
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet deflationProcedure or surgery
Tourniquet deflation
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet deflation | Tourniquet deflation after insertion of the prosthetic components during total knee replacement arthroplasty under spinal anesthesia Receives: Procedure: Tourniquet deflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathovagal balance
The ratio of low-to-high frequency power of heart rate variability calculated from the 5-minute long electrocardiogram waveform
Measured: During 5 minutes before tourniquet deflation
Secondary outcomes (2)
Noninvasive hemodynamic parameters
Average cardiac index
Measured: During 5 minutes before tourniquet deflation
Maximum percent change in mean arterial blood pressure
The discrepancy between minimum mean arterial blood pressure after tourniquet deflation and mean arterial blood pressure immediately before tourniquet deflation, which is divided by mean arterial pressure immediately before tourniquet deflation
Measured: During 10 minutes after tourniquet deflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start29 Jan 2014
- Primary completion29 Jul 2014
- Study completion30 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- JongHae Kim, M.D., Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408301
- Sponsor's protocol ID
- CR-13-071
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sympathovagal Balance Before Tourniquet Deflation on a Decrease in Arterial Blood Pressure Following the Deflation During Total Knee Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT03408301
- Acronym / sponsor ID
- CR-13-071
- Conditions
- Hypotension, Blood Pressure, Low
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 29 Jul 2014 (actual)
- Study completion
- 30 Jul 2014 (actual)
- First posted
- 24 Jan 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.
This study evaluates the influences of the status of sympathovagal balance before tourniquet deflation on a decrease in arterial blood pressure following the deflation during total knee replacement arthroplasty
Detailed description
Patients present with different hemodynamic profiles after intraoperative tourniquet deflation during total knee replacement arthroplasty.
Sympathovagal balance can be measured before tourniquet deflation and might determine the hemodynamic response to tourniquet deflation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tourniquet deflation | – | Procedure: Tourniquet deflationTourniquet deflation after insertion of the prosthetic components during total knee replacement arthroplasty under spinal anesthesia |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total knee replacement arthroplasty in a tertiary university hospital
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I - II
- Body mass index < 35 kg/m2
Key exclusion criteria (14 listed)
- Coagulation deficiencies
- Known allergies to local anesthetics
- Neurologic deficit on the side being operated on
- Inflammation at the lumbar puncture site
- Cardiac conduction disorders or arrhythmias
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 |
|---|---|---|
| Tourniquet deflationTourniquet deflation | Procedure or surgery | Tourniquet deflation |
Primary outcome
Sympathovagal balance
Time frame: During 5 minutes before tourniquet deflation
The ratio of low-to-high frequency power of heart rate variability calculated from the 5-minute long electrocardiogram waveform
2 secondary outcomes
Noninvasive hemodynamic parameters
Time frame: During 5 minutes before tourniquet deflation
Maximum percent change in mean arterial blood pressure
Time frame: During 10 minutes after tourniquet deflation
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 24 Jan 2018.
- 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.
JongHae Kim, M.D. principal investigator
Daegu Catholic University Medical Center
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 Hypotension and Blood Pressure, Low, run by Daegu Catholic University Medical Center at 1 site in South Korea.
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 2 inclusion and 14 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 24 Jan 2018. 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 South Korea. 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?
Sympathovagal balance (time frame: During 5 minutes before tourniquet deflation). 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 24 Jan 2018.