Propofol Concentration In The Ambient Air Of The Operating Room And In The Blood Of Anesthesia Care Providers
Information source: University of Medicine and Dentistry New Jersey
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Propofol Pollution
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Medicine and Dentistry New Jersey Official(s) and/or principal investigator(s):
Ming Xiong, PHD, MD, Principal Investigator, Affiliation: University of Medicine and Dentistry New Jersey
Summary
The pollution of the operating room environment by anesthetic agents had been questioned,
studied and documented in the past. These investigations demonstrated the existence of
teratogenic effects in animals and the possibility of a decrease in mental performance,
reduced fertility, fetal loss, spontaneous abortion and addictive potential in humans with
chronic exposure to trace amounts of anesthetic agents. These findings led to the
establishment of exposure limits and industry standards by consumer protection agencies, such
as National Institute for Occupational Safety and Health (NIOSH). However, these standards
applied to inhalation anesthetic agents that were excreted from the lungs of patients during
expiration. These concerns about operating room pollution weaned away with the introduction
of intravenous anesthetic agents, such as propofol, because it was believed propofol was
excreted by systems other than the lungs. Recent research points to the contrary and
demonstrates the excretion of propofol vapor in the expired gases of patients. Furthermore,
animal experiments in our laboratory establish the existence of a biological mechanism
responsible for addiction in animals exposed to trace amounts of propofol. We propose to
study the exposure levels of anesthesia care providers in the operating room, during propofol
use, under standardized conditions. Our findings will help to establish preventive measures
for propofol addiction in anesthesia care providers.
Clinical Details
Official title: Measurement Of Propofol Concentration In The Ambient Air Of The Operating Room And In The Blood Of Anesthesia Care Providers During Propofol -Based General Anesthesia
Study design: Cohort, Prospective
Primary outcome: Level of propofol in the air of the OR and blood of the anesthesia provider
Detailed description:
This clinical project will be carried out in the operating rooms of the University Hospital
and the Doctors Office Center. The study will be done during routine surgery where a
laryngeal mask airway will be used to maintain airway during general anesthesia in 20 adult
patients with American Society of Anesthesiologists physical status I or II. Routine
anesthetic care standards will be applied in intravenous line placement and monitoring of
patients. General anesthesia will be induced with a bolus dose of propofol (2mg. kg-1) and
maintained with an intravenous infusion of propofol (100-200 mcg. kg-1. min-1). Patients will
be allowed to breathe spontaneously 40% oxygen in air. Adjuvant intravenous medications will
be given for amnesia, analgesia and infection prophylaxis as per routine anesthetic practice.
The ambient propofol concentration will be measured, using a proton transfer reaction mass
spectrometer (PTR-MS), at a distance of 25cm from the patient's face. The measurement of
ambient propofol concentration will begin before the administration of propofol to the
patient and will continue till the patient leaves the operating room. The use of PTR-MS
device will not interfere with the anesthetic management of patient. In an unforeseen
circumstance, where the anesthesiologist determines the use of PTR-MS does interfere with the
anesthetic care of the patient, the device will be immediately removed and the measurement of
ambient propofol concentration will be suspended for the case. The set-up and usage of
PTR-MS will be performed by a research team that does not take part in the clinical
management of the patient. The PTR-MS is a device that depends on the proton transfer
reaction to quantify, in parts per billion (ppb) by volume, volatile organic compounds in air
at extremely low concentrations and in real time. The mean and peak ambient propofol
concentration will be determined during each case and a time weighted average (TWA) will be
calculated for an eight-hour period at the end of the study. In addition, after receiving
written informed consent from anesthesia care providers, blood samples will be drawn from
them and propofol concentrations will be measured by high-performance liquid chromatography
(HPLC) within 24hr. The blood samples will constitute 3ml on two occasions, one early in the
morning before anesthesia care starts and one after eight hours of anesthesia care. HPLC is
a device that uses a spectrofluorometric detector to estimate trace amounts of propofol in
blood in ng. ml-1. The blood estimation of propofol will also be conducted by a research team
that does not take part in the clinical management of patients.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- If you are over the age of 18- and under 65, and mentally capable of giving consent.
- If you are an Anesthesiology staff member.
- If you are scheduled to administer propofol during general anesthesia and surgery
Exclusion Criteria:
- If you refuse to sign consent.
- If you are not administering propofol within 8 hours after your first blood draw.
- If you are pregnant.
Locations and Contacts
UMDNJ, Newark, New Jersey 07101, United States
Additional Information
Starting date: June 2008
Ending date: July 2011
Last updated: June 11, 2008
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