HypotensionNCT03556969
Use of Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia: A Prospective Observational Study
An observational study of Hypotension and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This observational study is to evaluate Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypotension, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Observation
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2018to 15 Feb 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from both genders, ranging from young to very old patients.
Who may be able to join
- Adult patients having hip surgery under spinal anesthesia and propofol sedation
Who cannot join
- ASA class IV or above
- pregnancy
- inability to measure noninvasive blood pressure on the arm
- preexisting hemodynamic instability
- known peripheral artery occlusive disease
- known autonomic nerve dysfunction
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University, School of Medicine
Seoul, 06351
About this study
This observational study is to evaluate Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia.
- Being tested
- Observation
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Propofol sedation after SA | Participants who undergo propofol sedation after spinal anesthesia Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-minute perfusion index change
ability of perfusion index change 5 minutes after induction in predicting propofol sedation-induced hypotension (perfusion index change is calculated as the percent change from baseline values)
Measured: After sedation until start of surgery (an average of 20 minutes)
10-minute perfusion index change
ability of perfusion index change 10 minutes after induction in predicting propofol sedation-induced hypotension (perfusion index change is calculated as the percent change from baseline values)
Measured: After sedation until start of surgery (an average of 20 minutes)
baseline perfusion index
ability of baseline perfusion index in predicting propofol sedation-induced hypotension
Measured: After sedation until start of surgery (an average of 20 minutes)
5-minute perfusion index
ability of perfusion index 5 minutes after induction in predicting propofol sedation-induced hypotension
Measured: After sedation until start of surgery (an average of 20 minutes)
10-minute perfusion index
ability of perfusion index 10 minutes after induction in predicting propofol sedation-induced hypotension
Measured: After sedation until start of surgery (an average of 20 minutes)
Secondary outcomes (5)
5-minute perfusion index change difference
difference of perfusion index change 5 minutes after induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia (perfusion index change is calculated as the percent change from baseline values)
Measured: After sedation until start of surgery (an average of 20 minutes)
10-minute perfusion index change difference
difference of perfusion index change 10 minutes after induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia (perfusion index change is calculated as the percent change from baseline values)
Measured: After sedation until start of surgery (an average of 20 minutes)
baseline perfusion index difference
difference of baseline perfusion index between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia
Measured: After sedation until start of surgery (an average of 20 minutes)
5-minute perfusion index difference
difference of perfusion index after 5 minutes of induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia
Measured: After sedation until start of surgery (an average of 20 minutes)
10-minute perfusion index difference
difference of perfusion index after 10 minutes of induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia
Measured: After sedation until start of surgery (an average of 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start21 May 2018
- Primary completion30 Jan 2019
- Study completion15 Feb 2019
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.
- More trials run by Samsung Medical CenterThe 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
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556969
- Sponsor's protocol ID
- 2018-03-052
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2018
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03556969
- Acronym / sponsor ID
- 2018-03-052
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 14 Jun 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 observational study is to evaluate Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol sedation after SA | – | Other: ObservationParticipants who undergo propofol sedation after spinal anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from both genders, ranging from young to very old patients.
Key inclusion criteria (1 listed)
- Adult patients having hip surgery under spinal anesthesia and propofol sedation
Key exclusion criteria (7 listed)
- ASA class IV or above
- pregnancy
- inability to measure noninvasive blood pressure on the arm
- preexisting hemodynamic instability
- known peripheral artery occlusive disease
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 |
|---|---|---|
| Observationno intervention | Other | Propofol sedation after SA |
Primary outcome
5-minute perfusion index change
Time frame: After sedation until start of surgery (an average of 20 minutes)
ability of perfusion index change 5 minutes after induction in predicting propofol sedation-induced hypotension (perfusion index change is calculated as the percent change from baseline values)
10-minute perfusion index change
Time frame: After sedation until start of surgery (an average of 20 minutes)
ability of perfusion index change 10 minutes after induction in predicting propofol sedation-induced hypotension (perfusion index change is calculated as the percent change from baseline values)
baseline perfusion index
Time frame: After sedation until start of surgery (an average of 20 minutes)
ability of baseline perfusion index in predicting propofol sedation-induced hypotension
5-minute perfusion index
Time frame: After sedation until start of surgery (an average of 20 minutes)
ability of perfusion index 5 minutes after induction in predicting propofol sedation-induced hypotension
10-minute perfusion index
Time frame: After sedation until start of surgery (an average of 20 minutes)
ability of perfusion index 10 minutes after induction in predicting propofol sedation-induced hypotension
5 secondary outcomes
5-minute perfusion index change difference
Time frame: After sedation until start of surgery (an average of 20 minutes)
10-minute perfusion index change difference
Time frame: After sedation until start of surgery (an average of 20 minutes)
baseline perfusion index difference
Time frame: After sedation until start of surgery (an average of 20 minutes)
5-minute perfusion index difference
Time frame: After sedation until start of surgery (an average of 20 minutes)
10-minute perfusion index difference
Time frame: After sedation until start of surgery (an average of 20 minutes)
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 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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 Hypotension and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Samsung 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 1 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: finished, as of the sponsor's last update on 23 Aug 2022. 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?
5-minute perfusion index change (time frame: After sedation until start of surgery (an average of 20 minutes)). The study lists 5 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 23 Aug 2022.