Propofol Sedation in Outpatient Colonoscopy by Trained Practice

Transcription

Propofol Sedation in Outpatient Colonoscopy by Trained Practice
Original Manuscripts
Propofol Sedation in Outpatient Colonoscopy by Trained Practice Nurses Supervised by the Gastroenterologist: a Prospective Evaluation of over 3000 Cases
Propofol-Sedierung bei ambulanten Koloskopien durch ausgebildetes Assistenzpersonal im Team mit dem Gastroenterologen: eine prospektive Beobachtungsstudie bei ber 3000 Fllen
Author
A. Sieg
Affiliation
Praxis fr Gastroenterologie, Heidelberg, Germany nnn
Schlsselwçrter
" Propofol
l
" Sedierung
l
" gastrointestinale Endoskopie
l
" Koloskopie
l
" Sicherheit
l
" Komplikationen
l
" kardiorespiratorische
l
Ereignisse
Zusammenfassung
Abstract
!
!
Hintergrund: Propofol zeigt fr die Sedierung
von endoskopischen Untersuchungen einige
Vorteile. Die Sedierung durch Ansthesisten ist
mit hohen Kosten verbunden. In dieser Studie
wurde die Sicherheit der Propofol-Sedierung
durch ausgebildetes Assistenzpersonal im Team
mit dem Gastroenterologen in einer ambulanten
Fachpraxis fr Gastroenterologie in Deutschland
untersucht. Methoden: In diese prospektive
Beobachtungsstudie wurden alle Patienten aufgenommen, die whrend 21 Monaten zur Koloskopie berwiesen wurden. Das familire Risiko
der Individuen, die Indikation, Vollstndigkeit
und Ergebnisse der Koloskopie wurden zusammen mit der Propofol-Dosis registriert. Propofol
wurde durch intravençse intermittierende
Bolus-Titration von ausgebildeten Praxisassistentinnen unter berwachung durch den Gastroenterologen verabreicht. Whrend der Untersuchung wurden die Sauerstoffsttigung,
Herzfrequenz und Blutdruck kontinuierlich gemessen und unerwnschte kardiorespiratorische Ereignisse wurden durch das Endoskopieteam registriert. Ein respiratorisches
Ereignis wurde als eine Phase von Apnoe definiert, das eine assistierte Ventilation mit
Ambu-Beutel erforderlich machte. Bei 23 % der
Patienten wurde von Beginn der Untersuchung
an Sauerstoff ber eine Nasensonde appliziert.
Ergebnisse: Insgesamt wurden 3641 Koloskopien registriert. 33 Personen wurden mit Midazolam sediert und von der Auswertung ausgenommen. 3610 Personen wurden mit Propofol
sediert (119 € 39 mg, Mean € S. D.). 40 % der Untersuchungen wurden als kombinierte Gastroskopie und Koloskopie durchgefhrt. Das Zçkum wurde in 99 % der Koloskopien erreicht.
Respiratorische Ereignisse wurden bei fnf Patienten (0,14 %) beobachtet. In allen Fllen bestand die Atemhilfe in einer Maskenbeatmung.
Background and Study Aims: Propofol has several advantages for sedation in endoscopic procedures. Sedation administered by anaesthesiologists is associated with high costs. In this study
the safety of propofol sedation administered by
trained practice nurses under the supervision of
the gastroenterologist in a cohort of outpatients
of an ambulatory practice for gastroenterology
in Germany is evaluated. Methods: During a period of 21 months all patients referred to colonoscopy were eligible for this prospective observational study. The familiar CRC risk of the
individuals, indication, completeness and results
of the colonoscopy were registered together with
the dose of propofol used. Propofol was administered by intermittent intravenous bolus titration
by trained practice nurses under supervision of
the gastroenterologist. Oxygen saturation, heart
rate and blood pressure were recorded constantly during the procedure and adverse cardiopulmonary events were monitored by the endoscopy team. A respiratory event was defined as an
episode of apnoea or laryngospasm requiring assisted ventilation. 23 % of the patients received
supplemental oxygen. Results: A total of 3641
colonoscopies were recorded. 33 individuals
were sedated with midazolam and were excluded from the evaluation. 3610 individuals were
sedated with propofol (119 € 39 mg, mean dose €
S. D.). 40 % of the procedures were performed as
combined gastroscopy and colonoscopy. The cecum was reached in 99 % of the colonoscopies.
Respiratory events occurred in five patients
(0.14 %). Assisted ventilation in all cases was performed by mask ventilation. Bradycardia (HF
< 60/min) and arterial hypotension (RR
< 90 mmHg) occurred in 0.5 and 0.3 % of the colonoscopies, respectively, but medical intervention
was necessary only in 0.2 % for both types of
event. Minor events of hypoxaemia were ob-
Key words
" propofol
l
" sedation
l
" gastrointestinal endoscopy
l
" colonoscopy
l
" safety
l
" cardiorespiratory events
l
" complications
l
received
accepted
16.1.2007
6.6.2007
Bibliography
DOI 10.1055/s-2007-963349
Z Gastroenterol 2007; 45: 1 – 5
Karl Demeter Verlag im
Georg Thieme Verlag KG
Stuttgart · New York ·
ISSN 0044-2771
Correspondence
Prof. Dr. Andreas Sieg
Praxis fr Gastroenterologie
Rçmerstr. 7
69115 Heidelberg
Germany
Tel.: ++49/62 21/6 59 99 31
[email protected]
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Original Manuscripts
Bradykardien (HF < 60/min) und arterielle Hypotonie (RRsyst
< 90 mmHg) wurden bei 0,5 bzw. 0,3 % der Untersuchungen
beobachtet. Medikamentçse Interventionen waren aber bei
beiden Ereignissen nur in 0,2 % der Flle erforderlich. Ein geringgradiger Abfall der Sauerstoffsttigung mit spontaner Erholung wurde bei 51 Individuen beobachtet (1,4 %), wobei Patienten mit Sauerstoff-Supplementation nur zu einem Drittel
betroffen waren. Schlussfolgerungen: Propofol kann bei ambulanten Koloskopien durch ausgebildetes Assistenzpersonal unter sorgfltiger berwachung durch den Gastroenterologen sicher verabreicht werden.
served in 51 patients (1.4 %), but only 1/3 of these events occurred in patients supplemented with oxygen. Conclusions: Propofol can be administered safely for ambulatory colonoscopy by
trained practice nurses, with careful monitoring under supervision of the gastroenterologist.
Introduction
colorectal cancer (CRC), endoscopic diagnoses, adverse effects,
propofol dose, co-medication, completeness of colonoscopy (cecum rate), and combination with gastroscopy and polypectomy.
" Table 1.
The characteristics of the procedures are shown in l
Most of the patients were referred by general practitioners. 11 %
of all patients referred to colonoscopy showed a family risk (first
and second degree relatives with CRC). Polypectomy was performed in 10 % of all colonoscopies. The cecum was reached in
99 % of the cases. The reasons for incomplete colonoscopies are
" Table 2. 40 % of the procedures were performed as
shown in l
combined examinations of the upper and lower gastrointestinal
tract.
!
The introduction of screening colonoscopy into the National
Cancer Prevention Program in Germany in 2002 [1] has resulted
in an increasing number of endoscopic procedures. In 2003,
1020 000 curative colonoscopies and 537 000 preventive colonoscopies were performed; in 2004 the numbers increased to
1030 000 curative colonoscopies and 636 000 preventive colonoscopies [2]. More than 80 % of the procedures are performed
under sedation [3], which improves patient comfort and increases willingness to undergo repeat procedures [4]. The provision
of sedation is considered to be part of the colonoscopy procedure and separate billing for the administration of sedation is
not covered by insurance. The administration of propofol by anaesthesiologists will increase the costs of colonoscopy. Currently, the billing for sedation by anaesthesiologists in patients undergoing screening colonoscopy, which is offered to healthy
individuals over 55, is not generally reimbursed in Germany.
Propofol seems to be the ideal medication for sedation during
endoscopic procedures. It has a shorter onset time, faster patient
recovery and discharge [5 – 7], and higher patient satisfaction [5,
8]. One disadvantage of propofol is its ability to produce rapid
changes in neuropsychological functioning, from conscious sedation to deep sedation or even to narcosis with respiratory depression and apnoea. Another disadvantage is that there is no
antagonist.
Therefore, anyone administering propofol must be trained in
emergency medicine in order to be able to manage respiratory depression and apnoea by mask ventilation or intubation.
In the U.S.A. and Switzerland, nurse-administered propofol sedation (NAPS) under supervision of the gastroenterologist was
introduced some years ago with excellent results for safety [5,
6, 9 – 19]. These results may not be generalisable outside specialist centres. In Germany, there are no large reports on the
safety of propofol sedation.
This report describes the safety of propofol administered by
trained practice nurses under supervision of the gastroenterologist in an out-patient gastroenterology practice in Germany.
Methods
Table 1 Characteristics of 3641 colonoscopies performed in 1694 males and
1967 females (IM = internal medicine; FOBT = faecal occult blood test;
CIBD = chronic inflammatory bowel disease; CRC = colorectal cancer)
referring physicians
general practitioners
81 %
gynaecologists
4%
surgeons
1%
urologists
indication
1%
IM specialists
10 %
screening
44 %
positive FOBT
5%
hematochezia
9%
anaemia
2%
weight loss
lower abdominal pain
results
1%
17 %
chronic diarrhoea
4%
CIBD
4%
surveillance after polypectomy
6%
surveillance after CRC
2,5 %
CRC
polyps
1%
31 %
large polyps
diverticulosis
8%
20 %
enlarged Haemorrhoids
5%
CIBD
5%
normal finding
45 %
Table 2 Reasons for incomplete colonoscopies (39 of 3641 procedures
[1.07 %])
!
The study was approved by the ethics committee of the University of Heidelberg, Germany. The examinations were carried out
in the author’s outpatient practices in Bad Schçnborn (February
to December, 2005) and Heidelberg (January to September,
2006), Germany. All colonoscopies referred to the practice were
prospectively recorded. The following variables were registered:
patient’s age, sex, indication for the procedure, family risk of
reasons
n
malignant stenosis
10
diverticulosis/diverticulitis
2
stenosis in Crohn’s disease
5
benign stenosis following laparatomy
3
unclean colon
unknown reason for difficult examination (elongated colon etc.)
1
13
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Original Manuscripts
Practice nurses in Germany complete a three-year curriculum
with mostly practical training in outpatient practices. The
practice nurses administering propofol and the endoscopist
also completed a one-day training course which involved advanced cardiac life support, training of airway support with
mask ventilation and intubation, didactic training on propofol
and a written examination. The course for gastroenterologists
and their endoscopic teams is run by an anaesthesiologist
(www.mutzbauer.ch) who developed the curriculum in cooperation with gastroenterologists. The training includes one to
two days of internship in a gastroenterological practice where
propofol is administered by practice assistants supervised by
the gastroenterologist in at least 20 colonoscopies. A yearly
course in emergency resuscitation is recommended to the endoscopy teams.
Definition of events
An event was defined as an episode of apnoea or laryngospasm
requiring assisted ventilation, which in all cases was by bagmask. All events involved clinical evidence of prolonged poor
or absent respiratory effort or laryngospasm that was judged
clinically to warrant assisted ventilation. Minor events of hypoxaemia were defined as oxygen desaturation below 90 % for more
than 30 seconds and rapid spontaneous normalisation after verbal and tactile stimulation and supplementation with oxygen.
Bradycardia was defined as a heart rate below 60/min. Medical
intervention was performed at a heart rate below 40/min. Hypotension was defined as systolic pressure below 90 mmHg and
saline was infused when the systolic blood pressure dropped
below 80 mmHg.
The Wilcoxon test was used to compare mean arterial blood
pressure before and 5 min after administration of propofol.
Method of propofol administration
Sedation is voluntary and is offered to all patients scheduled
for endoscopy. About 99 % of the colonoscopies were performed under sedation. Exclusion criteria include allergy to
propofol or its components, patients with severe morbidity
(ASA class III and higher from cardiopulmonary cause), and
sleep apnoea. Subjects with ASA class III from a non-cardiopulmonary source were included in the study. Excluded patients requesting sedation are given midazolam. Propofol is
administered by intermittent intravenous bolus titration to
the necessary level of sedation as clinically judged by the
practice nurse and the endoscopist. In most cases, depending
on the age, body weight and co-morbidity of the subjects we
started with a 40 mg bolus followed by 20 mg boluses after 60
seconds, respectively, until the subjects reached the level of
conscious sedation. In 9 % of the examinations, 7.5 to 15 mg
of ketanest were used as analgesic agent in patients with a
difficult passage through the sigmoid colon when patients
deeply sedated with propofol were still agitated because of
pain. 23 % of the patients received supplemental oxygen at a
flow rate of 2 L/min. Oxygen supplementation is mandatory
in the elderly (over 75), in obese patients, and in patients
with a history of cardiopulmonary or cerebral events.
4The practice nurse administering propofol has no other tasks except to monitor the patient and administer sedation in continual
cooperation with the endoscopist. A separate individual assists
the endoscopist with the technical performance of the procedure.
The monitoring consists of continuous measurement of oxygen
saturation and heart rate and of regular measurement of blood
pressure. Blood pressure values were recorded before bolus injection of propofol and at 5 minute intervals thereafter. The data are
displayed on a monitor placed next to the endoscopy monitor so
that the endoscopist can see simultaneously the endoscopic picture and the vital data of the patient (heart rate, blood pressure,
and oxygen saturation). The primary monitoring of the endoscopy
team, however, is the clinical assessment of the patient, including
measurement of respiratory effort by visual assessment, by palpation of the chest wall and abdominal excursion, and/or by palpation of exhaled breath. In the case of a respiratory event during
upper GI endoscopy, the endoscope will be withdrawn within a
few seconds; whereas, in the case of a respiratory event during colonoscopy, the endoscope will be handed over immediately to the
second practice nurse, so the gastroenterologist is able to manage
the ventilation of the patient.
Results
!
A total of 3641 colonoscopies performed in 1694 males and
1967 females (mean age: 60 years) were recorded. Thirtythree individuals were sedated with midazolam and were excluded from the evaluation. 3610 individuals were sedated
with propofol (mean dose: 119 € 39 mg). There were no cases
requiring endotracheal intubation or resulting in death, neurological sequelae, or other permanent injury. Assisted ventilation was necessary in five cases with apnoea. No laryngospasm was observed. Thus, the overall respiratory event rate
" Table 3). Bradycardia occurred in 18 patients
was 0.14 % (l
(0.50 %), but medical intervention was necessary only in 6 of
them (0.17 %). 12 patients had arterial hypotension (0.3 %), 6
" Table 3).
of whom had to be infused with saline (0.17 %) (l
Minor events of hypoxaemia occurred in 51 patients (1.4 %).
Only one third of the hypoxaemias occurred in patients with
oxygen supplementation. In 324 patients propofol was combined with ketanest for analgosedation. Hypoxaemia occurred
in 0.9 % and arterial hypotension in 0.5 % of these individuals,
" Table 4
but apnoea and bradycardia were not observed. In l
major and minor respiratory events are shown as a function
Table 3 Event rate in 3610 colonoscopies sedated with propofol (mean dosage 119 € 39 mg)
event
number
apnoea
5
rate (%)
0.14
minor events of hypoxaemia
51
1.4
bradycardia, total
18
0.5
6
0.17
bradycardia with medical intervention
arterial hypotension, total
arterial hypotension with medical intervention
Table 4
12
0.3
6
0.17
Minor and major respiratory events as a function of time
study month
minor hypoxaemia (%)
apnoea (%)
0–6
1.3
0.26
7 – 12
0.8
0.11
13 – 18
2.5
0
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Table 5 Arterial blood pressure (mean € S. D.) before and 5 minutes after
bolus injection of propofol during colonoscopy
mean arterial blood
before
5 min after
pressure (mmHg)
propofol
propofol
systolic
144 € 27
127 € 21
diastolic
84 € 15
76 € 15
107 € 21
96 € 19
mean
p < 0.001
Table 6 Colonoscopies not indicated according to the German guidelines
(n = 136, 3.7 % of the total)
reason for lacking indication
number
rate
(%)
acute diarrhoea
41
30
wrong surveillance interval after polypectomy
27
20
wrong surveillance interval after surgery of CRC
21
15
wrong screening age
15
11
constipation in young patients (< 40 years)
9
7
changing bowel habits in young patients (< 30
years)
8
6
upper abdominal discomfort
6
4
surveillance not indicated after surgery of sigma
diverticulosis
5
4
melena
3
2
surveillance of coeliac disease
1
1
of time. The mean propofol dosage in patients with respiratory events (132 € 29 mg) was not significantly different from
that without events (119 € 39 mg). These patients had a mean
age of 63.4 years, which is not significantly different from the
mean age of cases without events (60.0 years).
Mean arterial blood pressure fell significantly from 107 € 21 to
" Ta97 € 19 mmHg (p < 0.001) after bolus injection of propofol (l
ble 5), but only six events occurred requiring infusion with saline. In most patients, the blood pressure immediately before
the beginning of the procedure was elevated compared to values
reported by the patients as their common values.
" Table 1.
The diagnoses found at colonoscopy are shown in l
Around 4 % of the colonoscopies were not indicated according
to the German guidelines. We still performed the procedures
because the patients arrived in the practice after colon lavage.
" Table 6.
The reasons for the lacking indications are shown in l
Discussion
!
This is the first prospective report on the safety of having propofol administered by practice nurses (supervised by the gastroenterologist) without involvement of anaesthetists in Germany. As
in other countries [21], the results of nurse-administered propofol sedation (NAPS) indicate that adequately trained nurses and
endoscopists can administer propofol and successfully recognise and treat episodes of apnoea requiring assisted (mask) ventilation. Serious respiratory events could be prevented by mask
ventilation, and there were no cases requiring endotracheal intubation or resulting in death, neurological sequelae, or other
permanent injury. Major respiratory events decreased over the
time of our study. As most of the minor events could be prevented by supplemental oxygen we generally recommend oxygen
supplementation for propofol sedation. Because the individual
event rates for nurses and gastroenterologists in the U.S.A. and
Switzerland after participating in NAPS programs were not different from the overall event rate [21], we recommend establishing effective training programs in Germany also. Gastroenterologists should not attempt NAPS without adequate training.
Respiratory dysfunction is the most common risk of propofol
sedation [5 – 7, 9 – 19]. Respiratory function was monitored
with clinical bedside methods and measurement of the oxygen
saturation. Other techniques such as capnography [7, 27 – 29]
would possibly result in earlier detection of apnoea and fewer
respiratory events than in the present study. Capnography is
not a generally recommended technique, however, and the
single-use material in Germany currently is too expensive to
introduce the procedure into ambulatory endoscopy. Data on
30-day morbidity or mortality were not collected. Thus, we
cannot determine whether NAPS is associated with an increased risk of post-procedural respiratory infections related
to aspiration during sedation.
Cardiovascular events were uncommon in the present study,
and less than 1 % of the patients had a clinically significant complication requiring medical intervention. Mean blood pressure
fell significantly after the administration of propofol, but nearly
all patients had elevated blood pressure values during the time
waiting for the procedure compared to the reported values measured at home. Thus, propofol seems to normalise previously
elevated blood pressure values rather than to induce hypotension.
Propofol administered by anaesthesiologists will significantly
increase the cost of endoscopy, and this procedure is not currently reimbursed for screening colonoscopy in Germany. NAPS
enables gastroenterologists to provide the advantages of propofol without raising the costs. There are, however, safety concerns from anaesthesia societies in the USA [22]. In Germany, a
published legal opinion by lawyers stated that propofol sedation has to be initiated by physicians educated in emergency
medicine and the ongoing sedation may be performed by nurses supervised by a physician [30]. A safer way to administer
propofol may be with new anaesthetic agents or forthcoming
machines that monitor and sedate patients. Another safer way
to administer propofol may be to combine it with midazolam
or opioids so that the dose of propofol may be lowered [31 – 33].
In the study by Rex et al., NAPS was easier and less likely to result in respiratory dysfunction when used in lower gastrointestinal endoscopy [21]. Programs developing NAPS might consider
starting with colonoscopy in the initial phase of the program.
The event rate of apnoea leading to mask ventilation decreased
successively during the 18 months of the study in contrast to
minor events of oxygen desaturation. This may be due to a learning effect of the endoscopy team that became used to the drug.
Obviously ketanest had no major effect on the complication rate.
The overall experience with non-anaesthetist-administered
propofol for endoscopic procedures now exceeds 100 000 patients [5 – 7, 9 – 19, 23]. These reports include no cases requiring endotracheal intubation or resulting in death. Safe propofol sedation of upper gastrointestinal endoscopy without an
anaesthetist was demonstrated even in children [24]. The administration of benzodiazepines for sedation by endoscopists
is a standard practice used in all countries even though seventy-three deaths from oversedation with midazolam were
reported to the U.S. Food and Drug Administration in the 4
years after its introduction [25]. In a meta-analysis, propofol
sedation in colonoscopy was associated with a lower odds ratio of cardiopulmonary complications than was midazolam
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[26]. For other procedures, the risk of complications was similar. In a recently published study there was a trend towards
an association of high doses (> 395 mg) of propofol with an
increased rate of events [21]. Furthermore, duration of sedation was determined as an independent risk factor for hypoxia
[10]. Thus, endoscopists should be alert to an increased risk of
a respiratory event during prolonged procedures. For shortlasting examinations like oesophagogastroduodenoscopy and
colonoscopy, NAPS seems to be a safe procedure.
In conclusion, trained endoscopy teams and gastroenterologists
can administer propofol safely for endoscopy.
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