Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
Recruitment status was Recruiting
|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|