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

Injections, Intravenous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01131741
• Other study ID #: 06-2009-141
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2010
• Last updated: February 13, 2011
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: February 2011
• Source: Seoul National University Hospital
• Contact: Jin Huh, MD
• Phone: 82-2-840-2510
• Email: huhjin419[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Injections, Intravenous

Intervention

Drug:
• Epinephrine
This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.
• Control
This group receives 3 mL of saline IV during operation.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	change of systolic blood pressure, heart rate, T-wave amplitude from baseline		during 5 min after injection of epinephrine containing test dose or saline	Yes