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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01131741

Enrollment

Registered

2010-05-27

Start date

2010-05-31

Completion date

2011-04-30

Last updated

2011-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injections, Intravenous

Keywords

anesthesia, general, blood pressure, epinephrine, heart rate, injections, intravenous

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.

Interventions

DRUGEpinephrine

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

DRUGControl

This group receives 3 mL of saline IV during operation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change of perfusion index from baseline	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

Measure	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

Countries

South Korea

Contacts

Primary ContactJin Huh, MD

huhjin419@gmail.com82-2-840-2510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026