Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
Recruitment status was Recruiting
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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 |
- 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.
- 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 |
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| Contact: Jin Huh, MD | 82-2-840-2510 | huhjin419@gmail.com |
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Jin Huh, MD huhjin419@gmail.com | |
| 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 Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013