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] Sieg A. Propofol Sedation in… Z Gastroenterol 2007; 45: 1 – 5 Gastro undi · Artikel 0003ga07-07, 4.7.07 · reemers publishing services gmbh 1 2 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 Sieg A. Propofol Sedation in… Z Gastroenterol 2007; 45: 1 – 5 Gastro undi · Artikel 0003ga07-07, 4.7.07 · reemers publishing services gmbh 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 Sieg A. Propofol Sedation in… Z Gastroenterol 2007; 45: 1 – 5 Gastro undi · Artikel 0003ga07-07, 4.7.07 · reemers publishing services gmbh 3 4 Original Manuscripts 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 Sieg A. Propofol Sedation in… Z Gastroenterol 2007; 45: 1 – 5 Gastro undi · Artikel 0003ga07-07, 4.7.07 · reemers publishing services gmbh Original Manuscripts [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. References 1 nnn. Richtlinien des Bundesausschusses der rzte und Krankenkassen ber die Frherkennung von Krebserkrankungen. Dtsch rztebl 2002; 11: 518–521 2 Knçpnadel J, Altenhofen L, Lichtner F et al. 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