Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|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|
- change of perfusion index from baseline [ Time Frame: during 5 min after injection of epinephrine containing test dose or saline ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131741
|Contact: Jin Huh, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Jin Huh, MD email@example.com|
|Study Director:||Jin Huh, MD||Seoul National University Hospital|