Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
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|ClinicalTrials.gov Identifier: NCT01131741|
Recruitment Status : Unknown
Verified February 2011 by Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : May 27, 2010
Last Update Posted : February 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Injections, Intravenous||Drug: Epinephrine Drug: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||April 2011|
This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.
|Placebo Comparator: Control||
This group receives 3 mL of saline IV during operation.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131741
|Contact: Jin Huh, MDemail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Jin Huh, MD firstname.lastname@example.org|
|Study Director:||Jin Huh, MD||Seoul National University Hospital|