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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Seoul National University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01131741

First received: May 23, 2010

Last updated: February 13, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 23, 2010

Last Updated Date

February 13, 2011

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change of perfusion index from baseline [ Time Frame: during 5 min after injection of epinephrine containing test dose or saline ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01131741 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

change of systolic blood pressure, heart rate, T-wave amplitude from baseline [ Time Frame: during 5 min after injection of epinephrine containing test dose or saline ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Injections, Intravenous

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Epinephrine
Intervention: Drug: Epinephrine
Placebo Comparator: Control
Intervention: Drug: Control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2011

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jin Huh, MD

82-2-840-2510

huhjin419@gmail.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01131741

Other Study ID Numbers ^ICMJE

06-2009-141

Has Data Monitoring Committee

Responsible Party

Jin Huh, MD., Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jin Huh, MD

Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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