Injections, IntravenousNCT01131741
Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
A study testing Epinephrine in people with Injections, Intravenous, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether changes in perfusion index can be used for detecting intravascular injection of an epinephrine in anesthetized adults and to compare its reliability with criteria using changes in heart rate, systolic blood pressure or T-wave amplitude. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Injections, Intravenous
- What is being tested?
- Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Apr 2011
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1 patients undergoing general anesthesia for elective surgery
Who cannot join
- emergent operation
- those who are taking anticoagulant medication, calcium channel blockers, or b-blockers
- laparoscopic operation
- history of smoking
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 110-744
Jin Huh, MD, huhjin419@gmail.com
About this study
Official title: Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate as an Indicator for Detecting Intravascular Injection of Epinephrine Containing Test Dose During Operation in Anesthetized Adults
The purpose of this study is to determine whether changes in perfusion index can be used for detecting intravascular injection of an epinephrine in anesthetized adults and to compare its reliability with criteria using changes in heart rate, systolic blood pressure or T-wave amplitude.
Read the detailed description
Intravenous injection of local anesthetics could result in life-threatening complications during general anesthesia. Physicians usually use local anesthetics containing epinephrine to detect intravascular injection. Existing methods including heart rate, systolic blood pressure and T-wave amplitude are unreliable to detect intravascular injection during anesthesia and a method using changes in perfusion index was recently suggested. This study was designed to determine whether perfusion index is a reliable method to detect intravascular injection of epinephrine containing local anesthetics and to compare its reliability with conventional criteria in sevoflurane anesthetized adults.
We will randomize patients to 2 groups: a saline group and an epinephrine group. Changes in perfusion index, systolic blood pressure, heart rate and T-wave amplitude will be measured during 5 minutes after injection of 3 mL of saline or 1% lidocaine containing epinephrine. we will determine sensitivity, specificity, positive predictive value and negative predictive value.
- Conditions
- Injections, Intravenous
- Being tested
- Epinephrine, Control
- Keywords
- anesthesia, general, blood pressure, epinephrine, heart rate, injections, intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.
ControlDrug
This group receives 3 mL of saline IV during operation.
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine | Experimental | Not described Receives: Drug: Epinephrine |
| Control | Placebo comparator | Not described Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of perfusion index from baseline
we will observe the change of perfusion index from baseline during 5 min after injection of epinephrine containing test dose or saline. Patients whose perfusion index decrease more than 25% are defined as positive response.we will obtain the sensitivity, specificity, positive predictive value, negative predictive value using perfusion index criteria to determine the reliability of perfusion index criteria.
Measured: during 5 min after injection of epinephrine containing test dose or saline
Secondary outcomes (1)
change of systolic blood pressure, heart rate, T-wave amplitude from baseline
Measured: during 5 min after injection of epinephrine containing test dose or saline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injections, IntravenousStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jin Huh, MD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131741
- Sponsor's protocol ID
- 06-2009-141
- Status last verified
- Feb 2011
- First submitted
- 23 May 2010
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate as an Indicator for Detecting Intravascular Injection of Epinephrine Containing Test Dose During Operation in Anesthetized Adults
- ClinicalTrials.gov ID
- NCT01131741
- Acronym / sponsor ID
- 06-2009-141
- Conditions
- Injections, Intravenous
- Keywords
- anesthesia, general, blood pressure, epinephrine, heart rate, injections, intravenous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 27 May 2010 (estimated)
- 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 purpose of this study is to determine whether changes in perfusion index can be used for detecting intravascular injection of an epinephrine in anesthetized adults and to compare its reliability with criteria using changes in heart rate, systolic blood pressure or T-wave amplitude.
Detailed description
Intravenous injection of local anesthetics could result in life-threatening complications during general anesthesia. Physicians usually use local anesthetics containing epinephrine to detect intravascular injection. Existing methods including heart rate, systolic blood pressure and T-wave amplitude are unreliable to detect intravascular injection during anesthesia and a method using changes in perfusion index was recently suggested. This study was designed to determine whether perfusion index is a reliable method to detect intravascular injection of epinephrine containing local anesthetics and to compare its reliability with conventional criteria in sevoflurane anesthetized adults.
We will randomize patients to 2 groups: a saline group and an epinephrine group. Changes in perfusion index, systolic blood pressure, heart rate and T-wave amplitude will be measured during 5 minutes after injection of 3 mL of saline or 1% lidocaine containing epinephrine. we will determine sensitivity, specificity, positive predictive value and negative predictive value.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine | Experimental | Drug: Epinephrine |
| Control | Placebo comparator | Drug: Control |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status 1 patients undergoing general anesthesia for elective surgery
Key exclusion criteria (4 listed)
- emergent operation
- those who are taking anticoagulant medication, calcium channel blockers, or b-blockers
- laparoscopic operation
- history of smoking
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 |
|---|---|---|
| EpinephrineThis group receives 3 mL of 1% lidocaine containing epinephrine IV during operation. | Drug | Epinephrine |
| ControlThis group receives 3 mL of saline IV during operation. | Drug | Control |
Primary outcome
change of perfusion index from baseline
Time frame: during 5 min after injection of epinephrine containing test dose or saline
we will observe the change of perfusion index from baseline during 5 min after injection of epinephrine containing test dose or saline. Patients whose perfusion index decrease more than 25% are defined as positive response.we will obtain the sensitivity, specificity, positive predictive value, negative predictive value using perfusion index criteria to determine the reliability of perfusion index criteria.
1 secondary outcome
change of systolic blood pressure, heart rate, T-wave amplitude from baseline
Time frame: during 5 min after injection of epinephrine containing test dose or saline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
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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.
Jin Huh, MD study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine in people with Injections, Intravenous, run by Seoul National University Hospital 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 4 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 15 Feb 2011. 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. Some participants in this study may receive a placebo. 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 Jin Huh, MD (82-2-840-2510, huhjin419@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of perfusion index from baseline (time frame: during 5 min after injection of epinephrine containing test dose or saline). 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 15 Feb 2011.