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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Injections, Intravenous

Intervention / Treatment
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* Drug: Epinephrine
* Drug: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epinephrine<br> | Drug: Epinephrine<br>* This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.<br>|
| Placebo Comparator: Control<br> | Drug: Control<br>* This group receives 3 mL of saline IV during operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of perfusion index from baseline | 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. | during 5 min after injection of epinephrine containing test dose or saline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of systolic blood pressure, heart rate, T-wave amplitude from baseline |  | during 5 min after injection of epinephrine containing test dose or saline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, general, blood pressure, epinephrine, heart rate, injections, intravenous