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Anesthesia and sedation outside the operating room:

how to prevent risk and maintain good quality.

ARTICLE in CURRENT OPINION IN ANAESTHESIOLOGY JANUARY 2008

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ACO/200228; Total nos of Pages: 7;
ACO 200228
Anesthesia and sedation outside the operating room: how to
prevent risk and maintain good quality
Claudio Melloni
Purpose of review
The purpose of this review is to define risks for anesthesia
and sedation outside the operating room, and to suggest
how to prevent these risks and maintain quality of care.
Recent findings
There are no recent data on risk for anesthesia outside the
operating room, except information derived from the
American Society of Anesthesia Closed Claims project,
which indicates there is a higher risk for office-based
anesthesia.
Summary
Complications of anaesthesia outside the operating room
are not well studied, although a few closed claims are
appearing in the literature suggesting there is a higher risk.
Topics discussed focus on MRI and surgical procedures,
principally dental, plastic, and gastrointestinal endoscopy.
Risk factors for these procedures are identified and
quantified and measures to reduce them discussed, with
emphasis on full oxygenation and end-tidal carbon dioxide
monitoring. Nonoperating room anesthesia requires skills,
experience and organization. Quality can only be assured by
ensuring all alternative locations adhere to operating room
standards.
Keywords
complications, liability, morbidity, mortality, nonoperating
room anesthesia, office-based anesthesia, risk
management
Curr Opin Anaesthesiol 20:000000. 2007 Lippincott Williams & Wilkins.
Consultant Anesthesist, Villa Torri Private Hospital, Bologna, Italy
Correspondence to C. Melloni, via Fossolo 28, 40138 Bologna, Italy
Tel: +39 0513 90048; fax: +39 0513 05034; e-mail: melloniclaudio@libero.it
Current Opinion in Anaesthesiology 2007, 20:000000
Abbreviations
GA general anesthesia
NORA nonoperating room anesthesia
2007 Lippincott Williams & Wilkins
0952-7907
Introduction
Identifying the risks in anesthesia means preventing
adverse outcomes and minimizing their impact when
they occur. The most common events in anesthesia
leading to injury were found to be respiratory [1]. A
recent report [2], however, suggests that cardiovascular
events actually represent the majority of complications.
While risks and complications of operating room anesthe-
sia have been defined leading to measures able to
minimize them [3], data on complications induced by
nonoperating room anesthesia (NORA) are scarce. Even
a monumental task such as the National Confidential
Enquiry into perioperative deaths (UK) [4] did not
distinguish between accidents occurring within or outside
the operating room. The American Society of Anesthesia
(ASA)-sponsored Closed Claims analysis [5] only recently
began to examine the litigation from office-based anesthe-
sia, concluding that the injury severity was greater than for
other ambulatory anesthesia claims.
As NORA may not follow the same patterns of compli-
cations as operating room anesthesia, statistics validated
in the operating room do not necessarily apply outside. It
is therefore of paramount importance to define the risks
of performing anesthesia outside the operating room. Our
discussion will encompass a few topics and be limited to
major morbidity and mortality.
Radiology: MRI and computerized axial
tomography scanning
Thirty-three cardiorespiratory arrests with 11 deaths were
reported in 2 045 954 patients undergoing MRI [6], giving
a complication rate of 16.1 per 1 000 000, that is 5.3 deaths
per 1 000 000 MRI procedures. Three hundred patients
undergoing MRI per year received sedation, but dis-
tinguishing between deaths in sedated and nonsedated
patients was not possible. Anesthesia or sedation is
needed because patients should not move during exam-
ination. All uncooperative patients should be anesthe-
tized, but anesthesia services and equipment are scarce
in MRI centers [7]. Since MRI is a highly expensive
technique, procedure prolongation through poor quality
imaging due to movement artifacts should be avoided.
Aborted procedures are costly, as well as inconvenient
for the patient, who would need to undergo repeat
imaging under general anesthesia (GA). Consequently,
the cost/efficacy of the anesthetic technique, and the
1
ACO/200228; Total nos of Pages: 7;
2 Ambulatory anaesthesia
failure rate, should be considered. The failure rate for
chloral hydrate is less than 5% [8,9], but even in the
absence of failures [10], prolonged sedation and emesis
take their toll and severe desaturation or adverse respir-
atory events have been noted [11]. Increasing chloral
hydrate syrup dosage to 100 mg/kg [12] was found to
increase the success rate but led to an incidence of
adverse reactions of 21%.
The efficiency of the procedure depends on the interval
from drug administration to scanning and emergence
quality: chloral hydrate needs time to act, and post-
discharge side effects can be disturbing, when not serious
[13], with a high percentage of prolonged sleepiness,
almost 70% unsteadiness, hyperactivity, poor appetite
and vomiting. Benzodiazepines [14,15] and barbiturates
[1618] do not rate any better.
Propofol requires a learning curve [19] and experience,
but offers short recovery times [20,21] and good mental
discharge. To avoid involuntary movements dosage
should be in the range of 100 mg/kg/min, corresponding
to a target controlled infusion level of around 2 mg/ml
[22]. An airway is needed in 20% of cases because of
respiratory depression, tracheal intubation being rarely
required [23]; simple manoeuvres like chin lift help to
maintain the airway [24]. The higher cost of the drug
is largely compensated by savings in postanesthesia
recovery and nursing times, with faster turnover rates
[25,26].
Imaging quality is better with spontaneous breathing
under pentobarbital sedation than with intermittent
positive-pressure ventilation/GA, which may lead to
atelectasis obscuring small pulmonary metastasis [27].
Five centimeters of positive end-expiratory pressure
(PEEP) completely prevents GA-induced atelectasis in
children [28].
The literature [29] and our experience have led to the
conclusion that, with the proper equipment, GA offers a
safer and time-effective way to provide conditions for
high-quality scans, accompanied by quick recovery.
The radiology department is probably the most demand-
ing area for anesthesia; their needs vary from resuscitation
of cranial disasters to monitored anesthesia care. The
main problems arise from irradiation and contrast media
reactions; complexity and demands also stem from inter-
actions with other specialists, such as gastroenterologists
and cardiologists.
Since sedation needs time to take effect, anxyolitics and
sedatives may be given before transferring the patient to
the procedural area. Among 118 serious adverse events
following premedication in children, including death and
permanent neurological injury, 12 occurred at home or
during transit [30].
Dental office
Approximately 300 000 patients per year undergo GA for
minor dental procedures in the UK [31]. In deaths
occurring on the dental chair (26 between 1984 and
1993) following cardiorespiratory failure, the postmor-
tems did not clarify the cause of cardiac arrest [32].
A mortality rate of nine in 1 000 000 was reported following
administration of oxygen/nitrous oxide/halothane [33].
The number of deaths in the UK, however, has decreased
from 100 (197079) to 20 (199099) [34,35]. Inappropriate
patient selection (ASA 3) may have contributed to anes-
thetic complications [36], but deaths in young healthy
patients have also been described [37]; overall, care was
judged to be poor.
The incidence of mortality in GA perfomed for dentistry
procedures has decreased in the latest reviews to 11.5
cases per million [38].
Pediatric sedation
Exploring sentinel events that is events that, if left
untreated, may progress to major accidents is crucial for
prevention. These events include hypoxemia, hypoven-
tilation, airway compromise, and unplanned hospital
admission. Hypoxemia was reported in 0.89% of chil-
dren sedated for MRI and computed tomography (CT)
[10,15,3942], and airway compromise was reported in
1.36% [4345]. Unscheduled hospital admission ranged
from 0.03 to 0.07% [46].
Nitrous oxide added to chloral hydrate increases hypo-
ventilation from 70% to almost 100% of patients, trans-
ferring them from consciousness to deep sedation [47].
Therapeutic endoscopy
The overall complication rate for upper gastrointestinal
endoscopy is 0.130.08%, with a mortality of 0.71 per
10 000. Cardiorespiratory problems account for half of
complications and 65% of deaths [48]. Most patients
receive sedation [49] with midazolam, diazepam and, more
recently, propofol. Intra and postprocedure occurrences
are strictly linked [50]; 69% of patients experience occur-
rences both during the procedure and the in-hospital stay.
The most common intraoperative complaints were pain,
hypertension, hypotension, bradycardia and oxygen desa-
turation, while hypotension, weakness, abdominal discom-
fort and dizziness followed the procedure in over 25%
of cases.
Sentinel events in gastrointestinal endoscopy were arter-
ial desaturation, ranging from 0.4% with oxygen to 70%
without, and tachycardia (3040%). Cardiac arrhythmias
ACO/200228; Total nos of Pages: 7;
occurred in 36% of patients with cardiopathy, 25% with
pneumopathy and 16% for apparently healthy individuals
[51].
Risk factors for adverse outcomes in endoscopy with
conscious sedation have been identified [52,53]. Topical
oropharingeal or nasal anesthesia is considered to be
absolutely safe but, besides methemoglobinemia [54],
significantly increases obstructive and central apnea [55].
The above considerations imply that patients, especially
if premedicated, should receive supplementary oxygen
[56], since arterial oxygen saturation in ambient air very
often ranges from around 89% to 92% after premedication
alone, and further declines during endoscopy and benzo-
diazepine plus opioid administration. In children, GA
with oxygen/nitrous oxide/halothane plus intubation
ensures higher oxygen saturation than midazolam seda-
tion after topical anesthesia [57].
Pharynx obstruction, tracheal compression, gastric dis-
tention, drugs, and local anesthesia contribute to oxygen
desaturation during esophagoduodenoscopy.
Sedation for diagnostic endoscopy is recommended
for ethical and physiological reasons, since sedation
and analgesia at least partially counteract the pro-
cedure-induced rise in cathecolamines, responsible
for hypertension and arrhythmias [58]. Complications
following endoscopy relate to team experience, with
some centers presenting excellent results [59] even in
extremely old patients [60]. Capnography is most useful
during and even after endoscopy, as it may identify
hypoventilation and apnea that may not emerge during
supplemental oxygenation [61].
The National Confidential Enquiry into perioperative
deaths (UK) [62] examined 1818 inpatient deaths within
30 days from gastrointestinal therapeutic endoscopy pro-
cedures. Fourteen percent of patients were judged to
have received excessive sedation; monitoring was poor in
23% of cases, and care was suboptimal in 27% of patients
with upper gastrointestinal bleeding. Thus, the quality of
care in these very often elderly and fragile patients needs
to be improved.
Office-based anesthesia, with special
emphasis on plastic surgery
Office-based anesthesia appears to be safe, as a 0.0017%
mortality rate (1/57 000) was reported in accredited
institutions [63], with better results in the office than
in ambulatory centers [64,65].
Greater figures may emerge from nonaccredited centers,
however, because plastic surgeons declared in a ques-
tionnaire [66] that respiratory arrest occurred in 13% of
Anesthesia outside the operating room Melloni 3
cases, unplanned intubations in 8%, local anesthetic
intravascular injection in 3% and there was 1% mortality.
Anesthesiologist attendance was rare.
Mortality following liposuction averaged 19.1 per 100 000
(one in 5000) [67], pulmonary embolism being the most
frequent killer [68].
Since 320 000354 000 liposuctions are performed yearly
in the USA [69], these data induced the Florida Board
of Medicine to declare on 10 August 2000 a 90-day
moratorium on office-based surgery because there is
an immediate danger to the health welfare and safety
of patients. An analysis of deaths 6 years later [70]
revealed 46 cases in more than 600 000 procedures per-
formed in the office. The great majority of these cases
were related to nonboard-certified plastic surgeons and
specialists in other fields, raising the issue of the creden-
tials of anesthesia providers. The guidelines for qualifica-
tions of anesthesia providers have been discussed by
the ASA [71], which documents that the door should
be left open to other anesthesia providers, like operating
physicians or other licensed physicians.
The mortality rate in the office is greater than in free-
standing centers and hospitals [72]. This contradicts
statements (founded on settled insurance liability claims)
that office-based liposuction is less risky than hospital-
based procedures, as the latter accounted for 71% of
malpractice claims compared with 21% in the office
setting [73].
Liability risks
NORA claims were found to more frequently involve
substandard care (63%) than operating room claims
(29%), and may be prevented by better monitoring,
Payments made, however, were similar in NORA and
operating room claims [74]. NORA claims have
increased sixfold over the decades (from 0.2% in the
1970s to 1.2% in the period 19902001). Other specialists
may be more exposed [75].
Special problems of NORA
NORA problems derive from remote locations, limited
working space, electrical interference with monitors and
phones, lighting and temperature inadequacies, lack of
skilled personnel, drugs, and supplies.
Noises are unsettling for the patient and disturb the
anesthesiologist. As alarm recognition occurs 34% of
the time under ideal conditions [76], noisy areas like
MRI centers make sound recognition and alarm percep-
tion very difficult. A presumed reason is that many alarms
have similar sounds [77]. Since alarm volume and recog-
nition rate are correlated, we suggest that alarms be set at
maximum levels in NORA environments.
ACO/200228; Total nos of Pages: 7;
4 Ambulatory anaesthesia
Inside the operating room every effort is made to access
the patient easily; when this is not possible, special
equipment and precautions are needed. Bulky equip-
ment may impede access to the patient and warrant
airways to be secured even for minor procedures.
AQ1 Anesthesiologist(s) . . . and not only, other consultants
as well.
The National Confidential Enquiry into perioperative
deaths (UK) [62] found that the number of yearly pro-
cedures performed by some consultant endoscopists was
too low to ensure proficiency and skill. It recommended
that competency in endoscopy should be assured by
national guidelines. No such recommendations exist
for anesthesiologists, however, whose competency is
simply assumed by the specialist diploma.
NORA requires special skills and attitudes; for instance,
among 25 neuroanesthesiologists, only three were found to
administer anesthesia with the magnet inside the operat-
ing room [78], intrinsically recognizing the need for a
higher level of technical skills. Nontechnical skills are also
important [79], since NORA also stresses other qualities,
like task management, team-working capability and
coordination, situation awareness, and decision-making.
Since NORA involves special risks and difficulties, anaes-
thetists that are unsafe due either to a lack of knowledge
and skills or old age need to be identified [80,81].
Many centers and countries have adopted the post of
sedationist. In Italy, this task is very often assumed by
the physician performing the procedure, but nurses have
been more and more involved, with excellent results and
enviable safety records [8,14].
The issue of quality of care and outcome has been raised
[13], and the cost implications of anesthesia services [82].
Anesthesia is a discipline that requires the constant
vigilance of well trained and experienced providers;
safety derives from high-level dedicated care, teamwork,
and rapid availability of physicians, especially during
medical crises. Clinical evidence supports the anesthe-
siologist-led anesthesia care team as the safest and most
cost-effective method of delivering anesthesia. Death
and failure to rescue were more frequent when care
was not directed by anesthesiologists [83]. The reasons
behind nurse rather than physician organizations are
likely economic, since nurses cost less [84], are probably
more attentive to protocols, and may be more manipu-
lated by economy. The debate [85] will continue for a
while, at least in countries where certified registered
nurse anesthetists are numerous and well trained.
Sedation cannot be restricted to anesthesiologists.
Even though practitioners should be able to administer
sedative and hypnotics titrated to effect, this is not the
case, so the ASA published its Practice guidelines for
sedation and analgesia by non-anesthesiologists [86],
which have been endorsed by several scientific colleges
and associations.
I believe that the main questions are as follows: what
would happen when a patients condition abruptly
changes or the patient moves to another stage of seda-
tion? Who would be responsible for complications? Since
every patient may become unstable, every single seda-
tion analgesic given outside the operating room should be
done by one anesthesiologist/patient/unit of time, and
the anaesthesiologist should be an experienced intensi-
vist should a crisis occur.
Patients
Patients undergoing NORA may be more ill than those
attending an operating room, as most NORA claims
involve higher-risk, elderly patients undergoing nonemer-
gency surgery [72]. Preanesthetic preparation is very often
done by others, who may not consider the interactions
between a patients physical condition, medications taken
and the effects of anesthesia.
Quality issues
Quality improvement should rely on raising the standards
of every location where sedation and anesthesia are
possible to operating room standards. In the meantime,
the following recommendations taken from the ASA
guidelines for NORA locations [87] should be followed
and implemented.
(a) Reliable oxygen source including a backup supply.
(b) Adequate and reliable suction.
(c) Adequate and reliable scavenging system if anes-
thetic gases are to be used.
(d) Self-inflating resuscitation bag capable of delivering
an inspired oxygen fraction (FiO2) of 0.90.
(e) Adequate drugs, supplies and equipment for the
planned activity.
(f) Adequate monitoring equipment to adhere to stan-
dards for basic anesthetic monitoring.
(g) Sufficient electrical outlets, isolated electric power
or electric circuits with ground fault interruption
in wet areas like cystoscopy, arthroscopy, labor
and delivery suites, with access to emergency power
supply.
(h) Sufficient space for equipment and personnel and
transportation.
(i) Immediate suitability of an emergency cart with
defibrillator, emergency drugs, etc.
(j) Reliable two-way communication.
(k) Observation of all applicable building and safety
codes and facility standards.
(l) Appropriate postanesthesia management.
ACO/200228; Total nos of Pages: 7;
A reliable source of oxygen adequate for the procedure
duration and a backup supply are critical. Virtually all
facilities in which anesthesia is administered are
equipped with a central gas supply system, at least in
the more industrialized countries. Cylinders (E type) are
rarely seen on anesthesia machines today; if anesthesia is
to be delivered in a location without a central medical gas
supply, the anesthesiologist and local personnel must first
ensure that an adequate supply of oxygen is available.
The gas amount left in the cylinder must be continuously
monitored and the cylinder replaced before it is com-
pletely empty. As a rule of thumb, an E cylinder of
5 l capacity at a pressure of 200 atm roughly contains
1000 l of oxygen; at a pressure of 135 atm, 660 l, and at
100 atm, 500 l. If 6 l/min are consumed, a full cylinder will
last 160 min; if half empty, 80 min. If oxygen is delivered
without flowmeters, its consumption is unknown and
extra care is recommended.
Equipment in nonoperating room anesthesia
Old equipment is often kept in NORA areas, so new
anesthesiologists may be unfamiliar with it and machines
may no longer meet standards. Since such equipment is
not used on a daily basis, it has to be carefully checked
before each use and a program of maintenance should be
instituted. The same considerations apply for monitors.
How to proceed
After carrying out an anesthestic and monitoring equip-
ment check, the anesthetic plan should be followed but
the anaesthesiologist should always be prepared for a
change in procedure. The few data available do not seem
to prefer monitored anesthesia care to GA. Bhananker
et al. [88] found the same mortality and morbidity rates
during monitored anesthesia care with a greater pro-
portion of respiratory depression after absolute or relative
overdose of sedative or opioid drugs. It is my personal
opinion that sedation and analgesia with spontaneous
respiration requires greater skills and experience than
general anesthesia with airway control. Monitored
anesthesia care for disabled children is much less expens-
ive in the dental rehabilitation office than GA in the
operating room, but more sentinel events have been
reported [89].
All data should be obtained during the procedure, especi-
ally when the anaesthesiologist is away from the patient;
this may require remote monitoring, special extension
tubing, among other means. The anaesthesiologist
must be prepared for bad surprises, including sudden
movement of the patient, allergies, anaphylactic shock,
and need for vasopressors.
Postoperative surveillance/transportation
Almost all the potentially preventable office-based inju-
ries result from adverse respiratory events in the recovery
Anesthesia outside the operating room Melloni 5
or postoperative periods [5]; therefore, strict surveillance
should be exercised until full recovery.
During transportation all the equipment necessary for a
safe journey should be at hand. The ideal recovery area
should be near the location where the patient was
treated. The safe solution is to place patients in the
postanesthesia care unit (PACU) or recovery room, as
for surgical patients.
Measures of outcome
Critical incidents may be more frequent in NORA;
emergency treatment of airways is paradigmatic [90].
The availability of a difficult intubation cart in the
ICU or PACU that can be called upon for rescue would
be optimal, but distant locations should have their emer-
gency trolley with a reasonable choice of airways. Since
outcome is influenced by care quality [91], specific pro-
tocols should be adopted for NORA and personnel
organized accordingly.
NORA activities require time, which means adequate
staffing: consider how many NORA activities should be
covered every day. An invitation is being made to sche-
dule fixed days for different tasks in order to organize the
anesthesia services.
Conclusion
No anesthesia or sedation performed outside the operat-
ing room should be considered minor; it requires skill,
experience, and organization. Anesthetic needs should be
evaluated from a safety point of view. Patient prep-
aration, consent, sedation, analgesia or GA should be
performed utilizing the same standards as adopted for
the operating room.
References and recommended reading
Papers of particular interest, published within the annual period of review, have
been highlighted as:
 of special interest
 of outstanding interest
Additional references related to this topic can also be found in the Current
World Literature section in this issue (pp. 000000).
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