“‘Awake’
will do to surgery what ‘Jaws’ did to
swimming in the ocean.”
— Movie producer Joana Vicente, commenting
on her movie “Awake,” a “psychological
thriller” scheduled for a 2006 release that
tells the story of a man who is awake but paralyzed
during surgery.1
 nintended
awareness during general anesthesia (“recall,”
“awareness”) occurs with a frequency
of less than 1 in 500 general anesthetics.2
The public profile of this complication of general
anesthesia in recent years, however, has been second
to none. Even without any increased attention that
the upcoming movie may generate, public awareness
and concern have been raised by the campaigns of
patients who have suffered from recall, news media
coverage on the topic, portrayals of recall in medical
dramas on television and the increasingly public
profile of brain function monitors for the assessment
of the depth of anesthesia in clinical practice.
All of this has created an environment where anxious
inquiries by patients regarding recall under general
anesthesia are now a routine occurrence during preanesthetic
assessments.
The ASA Closed Claims Project database3
was reviewed to evaluate factors associated with
liability for awareness during anesthesia in the
1990s. The database contains standardized information
on 6,894 closed anesthesia malpractice claims from
35 professional liability insurance companies throughout
the United States. Claims for dental damage are
excluded from the database. Claims for awareness
were classified into “awake paralysis,”
i.e., the accidental paralysis of an awake patient,
and “recall during general anesthesia,”
i.e., explicit recall of events while receiving
general anesthesia. The latter category is what
is typically thought of as “awareness”
during anesthesia and ranges from mild to more pronounced
recall.
Overview of Claims for Awareness
Awareness claims formed 2 percent [Figure 1] of
all claims from 1990 to 2001, including 56 claims
for recall under general anesthesia and nine claims
for awake paralysis. The rate of payment for awareness
claims was about the same as for claims for other
complications in the database (52 percent), although
payments were smaller than for other claims in the
database. Payments for awareness, adjusted to 1999
dollars using the consumer price index, remained
constant compared to earlier decades [Table 1].
The median payments for recall remain less than
the $50,000 threshold cited by Huycke and Huycke4
in 1994 as the compensation level above which attorneys
become more interested in pursuing claims. There
was a broad range of payments, however, with one
as high as $840,000 for a patient undergoing coronary
artery bypass grafting who suffered from post-traumatic
stress disorder after intraoperative recall of the
surgical procedure. The size of this payment was
influenced by substandard care compounded by poor
record keeping and lack of postoperative follow-up.
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Awake Paralysis, 1990-2001
Nine claims for awake paralysis were analyzed separately
because the factors associated with these claims
are substantially different from the more heterogeneous
claims for recall. Awake paralysis claims were related
to syringe identification errors, out-of-sequence
administration of induction agents and the use of
succinylcholine infusions. Most (78 percent) represented
substandard care, and payments were made in most
(56 percent) cases. The median payment amount, however,
was relatively small ($20,000).
Recall During General Anesthesia Claims, 1990-2001
Claims for recall (n = 56) accounted for 2 percent
of the 1,977 general anesthesia claims in 1990-2001.
Payment was made in 52 percent of recall claims.
The median payment of $34,049 was substantially
lower than payment for other complications associated
with general anesthesia ($152,500, p<0.05). Mechanical
problems with vaporizers or ventilators contributed
to light anesthesia in 9 percent of recall claims.
The management of a difficult airway was associated
with 2 percent of claims. A large number of claims
were not associated with any single obvious factor,
but there were indications that lower doses of anesthetic
agents may be associated with recall.
Awareness is a more substantial liability burden
for cardiac anesthesiologists as cardiac procedures
accounted for 23 percent (13 of 56) of recall claims
but only 6 percent (124 of 1,921) of general anesthesia
claims (p<0.05). This result correlates with
data from other sources5
suggesting that this group of patients is at a high
risk for awareness because of their potential for
hemodynamic instability and limited tolerance of
anesthetic agents.
Women accounted for 73 percent of recall claims
and only 52 percent of other claims (p<0.05).
The higher-risk situation of general anesthesia
for cesarean section obviously affects only female
patients. In addition the increase in claims from
women may represent a gender-related increase in
propensity for recall during general anesthesia
as women have higher requirements for both propofol6
and opioids.7
Discussion
Our present review indicates that there has been
no substantial change in the liability associated
with recall under general anesthesia in the 1990s
compared to previous decades. It is important to
note, though, that it takes, on average, three to
five years after the complication for the claim
to be resolved and included in the Closed Claims
Project database. Hence recent changes in liability
for awareness are not represented in this review
of claims.
In 2004 the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) issued a sentinel
event alert on the prevention and management of
awareness.8
Well before the sentinel event alert was released,
ASA had begun organizing and planning the work of
its Task Force on Brain Function Monitoring and
Intraoperative Awareness to review the problem of
awareness, and this task force created the “Practice
Advisory for Intraoperative Awareness and Brain
Function Monitoring.”9Neither
the JCAHO alert nor the ASA practice advisory alluded
to any significant change in the standard of care
for prevention of awareness.
It remains unknown whether the public perception
of what can be done for the prevention of awareness
has changed. Brain function monitors for the assessment
of the depth of anesthesia were in limited use and
under clinical study in the 1990s and early 2000s.
This development, having been brought to the public’s
attention by media coverage, may have generated
the perception among patients, lawyers and potential
jurors that the standard of care for the prevention
of intraoperative awareness has changed. If so,
the frequency of claims by patients, the willingness
of lawyers to take on these claims and the determination
of payment amounts for claims could represent a
potential for increased liability burden.
References:
1. <www.variety.com/article/VR1117928380?cs=1&s=h&p=0>.
Last accessed May 16, 2006.
2. Sebel PS, Bowdle TA, Ghoneim MM, et al. The incidence
of awareness during anesthesia: A multicenter United
States study. Anesth Analg. 2004; 99:833-839.
3. Cheney FW, Posner K, Caplan RA, et al. Standard
of care and anesthesia liability. JAMA.
1989; 261:1599–1603.
4. Huycke LI, Huycke MM. Characteristics of potential
plaintiffs in malpractice litigation. Ann Int
Med. 1994; 120:792-798.
5. Phillips AA, McLean RF, Devitt JH, et al. Recall
of intraoperative events after general anesthesia
and cardiopulmonary bypass. Can J Anaesth.
1993; 40:922-926.
6. Gan TJ, Glass PS, Sigl J, et al. Women
emerge from general anesthesia with propofol/alfentanil/nitrous
oxide faster than men. Anesthesiology.
1999; 90:1283-1287.
7. Drover DR, Lemmens HJ. Population
pharmacodynamics and pharmacokinetics of remifentanil
as a supplement to nitrous oxide anesthesia for
elective abdominal surgery.
Anesthesiology. 1998; 89:869-877.
8. Joint Commission on Accreditation of Healthcare
Organizations (JCAHO): Preventing, and managing
the impact of, anesthesia awareness. Sentinel Event
Alert, October 6, 2004.
9.
American Society of Anesthesiologists Task Force
on Brain Function Monitoring and Intraoperative
Awareness: Practice Advisory for Intraoperative
Awareness and Brain Function Monitoring.
A report by the American Society of Anesthesiologists
Task Force on Intraoperative Awareness. Anesthesiology.
2006; 104: 847-864.
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Christopher
D. Kent, M.D., is Assistant Professor, University
of Washington School of Medicine, Department
of Anesthesiology, Seattle, Washington. |
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