Clinical Trials Directory

Trials / Unknown

UnknownNCT01131741

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
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGEpinephrineThis group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.
DRUGControlThis group receives 3 mL of saline IV during operation.

Timeline

Start date
2010-05-01
Primary completion
2010-07-01
Completion
2011-04-01
First posted
2010-05-27
Last updated
2011-02-15

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01131741. Inclusion in this directory is not an endorsement.