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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
  Purpose

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.


Condition Intervention
Injections, Intravenous
Drug: Epinephrine
Drug: Control

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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epinephrine Drug: Epinephrine
This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.
Placebo Comparator: Control Drug: Control
This group receives 3 mL of saline IV during operation.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131741

Contacts
Contact: Jin Huh, MD 82-2-840-2510 huhjin419@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jin Huh, MD       huhjin419@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Jin Huh, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jin Huh, MD., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01131741     History of Changes
Other Study ID Numbers: 06-2009-141
Study First Received: May 23, 2010
Last Updated: February 13, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
anesthesia, general
blood pressure
epinephrine
heart rate
injections, intravenous

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014