Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 23, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFebruary 15, 2011
February 1, 2011
2 months
May 23, 2010
February 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
change of systolic blood pressure, heart rate, T-wave amplitude from baseline
during 5 min after injection of epinephrine containing test dose or saline
Study Arms (2)
Epinephrine
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.
Eligibility Criteria
You may qualify if:
- ASA physical status 1 patients undergoing general anesthesia for elective surgery
You may not qualify if:
- emergent operation
- those who are taking anticoagulant medication, calcium channel blockers, or b-blockers
- laparoscopic operation
- history of smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Seoul, 110-744, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jin Huh, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 23, 2010
First Posted
May 27, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2010
Study Completion
April 1, 2011
Last Updated
February 15, 2011
Record last verified: 2011-02