Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
|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 ]
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|