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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- change of perfusion index from baseline
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA physical status 1 patients undergoing general anesthesia for elective surgery
Exclusion Criteria
- •emergent operation
- •those who are taking anticoagulant medication, calcium channel blockers, or b-blockers
- •laparoscopic operation
- •history of smoking
Arms & Interventions
Epinephrine
Intervention: Epinephrine (Drug)
Control
Intervention: Control (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- change of systolic blood pressure, heart rate, T-wave amplitude from baseline(during 5 min after injection of epinephrine containing test dose or saline)