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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

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.

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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.

Conditions

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Injections, Intravenous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Epinephrine

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

This group receives 3 mL of saline IV during operation.

Interventions

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Epinephrine

This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.

Intervention Type DRUG

Control

This group receives 3 mL of saline IV during operation.

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No