Sedation at Endoscopic Units in Galicia: results of the "Sociedad Gallega de Patología Digestiva" inquiry

J. Cubiella Fernández, A. Lancho Seco, A. Echarri Piudo, J. L. Ulla Rocha, J. Fernández Seara on behalf of Sociedad
Gallega de Patología Digestiva

Service of Digestive Diseases. Complexo Hospitalario. Ourense, Spain

 

ABSTRACT

Aim: to evaluate the human and material resources available for sedation, and the usual manner of handling them at endoscopic units in Galicia.
Methods: a prospective and descriptive study based on the performance, distribution, and analysis of a clinical practice inquiry. We requested information about endoscopies performed, available means for sedation, sedation monitoring, and level of sedation used in each procedure.
Results: our inquiry was answered by twenty endoscopic units (thirteen were in public hospitals, and eleven performed complex procedures). Of these units, 80% had a pulse oximeter, 42% had continuous electrocardiography, 40% had a defibrillator, and 45% had a recovery area. The drug most commonly used in gastroscopies was midazolam (76%), and the combination midazolam-meperidine was most frequent in both colonoscopies (72%) and ERCPs (60%). An anesthesiologist was usually available for certain procedures in 15% of units, and as an exception in 65%. Of those inquired, 35% wished to have a full-time anesthesiologist in the unit, 25% wished to have an anesthetist only for certain procedures, and 35% on an exceptional basis. Finally, endoscopists considered that 83% of therapeutical gastroscopies, 87% of therapeutical colonoscopies, 98% of ERCPs, 95% of enteroscopies, and 98% of echoendoscopies deserved sedation.
Conclusions: although endoscopists consider that endoscopic procedures should benefit from sedation in a high proportion, the available resources to safely monitor patients are inadequate in some units.

Key words: Endoscopy, gastrointestinal. Proffesional practice. Conscious sedation. Sedatives. Drug. Complications.

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Cubiella Fernández J, Lancho Seco A, Echarri Piudo A, Ulla Rocha JL, Fernández Seara J on behalf of Sociedad Gallega de Patología Digestiva. Sedation at Endoscopic Units in Galicia: results of the "Sociedad Gallega de Patología Digestiva" inquiry. Rev Esp Enferm Dig 2005; 97: 24-37.

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Recibido: 03-03-04.
Aceptado: 15-06-04.

Correspondencia: Joaquín Cubiella Fernández. Servicio de Aparato Digestivo. Complexo Hospitalario de Ourense. Rua Ramón Puga, 52-54. 32003 Ourense. Telf.: 988 385 715 - Fax: 988 385 518. e-mail: joaquin.cubiella.fernandez@sergas.es

 

INTRODUCTION

Sedation in digestive endoscopy is an important part of everyday's clinical practice. Depending on the country, routine use ranges from 44 to 72% (1). Even though it increases tolerance in some explorations (2), sedation is also related to an increased morbidity rate, especially from cardiopulmonary complications (3-6). These complications arise in relation to age and associated conditions (4,6). Therefore, not only should endoscopists use drugs, but they also should have available the necessary means and knowledge to monitor the patient during the procedure. Although consensus documents and recently published clinical guidelines detail the minimum requirements for correct sedation and monitoring (3-5), our inquiry on sedation at endoscopy units shows great variability both in sedation type and the available means for patient monitoring (7-9).

Sociedad Gallega de Patología Digestiva (SGPD) is the gastroenterologists' representative society in Galicia. Following a program introduced for a better knowledge of clinical practice in the Galician region, an evaluation of sedation patterns at endoscopy units was undertaken that took examination type into account. The aim of this study was to find out the available means, regular method of sedation, and sedation method desired by endocopists at endoscopy units in Galicia.

MATERIAL AND METHODS

Investigation design

A prospective and descriptive research on the performance, distribution, and analysis of an inquiry on clinical practice.

Questionnaire elaboration

The inquiry was set by the authors on the basis of a review of clinical guidelines, consensus documents, and sedation inquiries published (2,4,6-8). Once a consensus was reached, the inquiry was submitted to the SGPD direction board. The direction board approved the questionnaire and its sending to regional endoscopy units. A copy of this questionnaire is included in table I.

Sedation definitions

Definitions used were already described in the literature (3-5). Thus, conscious sedation was defined as a technique in which the administration of a drug induces a depression of the central nervous system that allows exploration, and during which the verbal contact with the patient is maintained and both the breathing and cardiovascular functions are stable. In contrast, deep sedation was defined as a type of sedation in which the patient has no responses to verbal or painful stimuli, and may not keep an open airway, thus often requiring breathing support.

Inquiry submission

Searching through Catálogo de Hospitais Galicia 2000, published by Secretaría General del Servicio Gallego de Salud (SERGAS), 29 endoscopy units were identified in hospitals throughout the Galician region. Of these units, 17 were in public hospitals (14 belonged to the SERGAS network, two to public foundations, and one to a military hospital), two were in state-assisted private hospitals, and 10 in private hospitals. Questionnaires were sent by mail to the specialist in charge of each unit in March 2003. Two months later, units that had not answered the inquiry were contacted by telephone, and the inquiry was mailed once again.

Statistical analysis

A descriptive analysis of answers was performed. We performed a univariate analysis in order to detect differences between private and public hospitals and between those that made highly complex explorations (ERCPs, enteroscopies, echoendoscopies) and those that did not. Fisher's exact test was used for qualitative variables, and Mann-Whitney's test for quantitative variables. Differences were considered statistically significant when p < 0.05. The statistical analysis was performed using the SPSS 10.0 statistical package.

RESULTS

Unit characteristics

The questionnaire was answered by 20 endoscopy units. Thirteen of the responding units were public (11 belonged to the SERGAS network, one was a foundation, and one was a military hospital) and seven were private (two state-assisted private hospitals). Of these 20 units, 11 performed complex explorations (ERCP 11, enteroscopies 6, echoendoscopies 3). The volume and type of explorations is shown in table II.

Available materials and human resources

The material resources and drugs available for sedation in these endoscopy units are listed in table III. A univariate analysis has only identified significant statistical differences (p = 0.026) in pulse oximetry availability between units practicing complex explorations (11/11) and units not practicing complex explorations (5/9). On the other hand, the median of beds in recovery rooms was 2.5 (range 1-6); eight of the recovery rooms had pulse oximetry and oxygen, four had blood pressure and electrocardiography monitoring, six had a crash cart, and five had a defibrillator. Regarding anesthetists availability, none of the units had a permanent anesthetist. Fifteen percent of units had an anesthetist only for complex explorations, but on a common basis. Thirty percent of units had an anesthetist immediately when required, but that rarely happened. Forty-five percent of the units could not have an anesthetist immediately, his/her presence having to be scheduled beforehand. Finally, 30% of units never had an anesthetist, and had to use an operation theater for explorations.

Common method of sedation

On the one hand, the number of units performing more than 50% of diagnostic and therapeutic gastroscopies with sedation was 7/11 and 11/18, respectively; of diagnostic and therapeutic colonoscopies was 11/20 and 14/19, respectively; of ERCPs was 11/11; of enteroscopies was 5/6, and of echoendoscopies was 2/3. On the other hand, even though midazolan was the most used drug for sedation in gastroscopies, both diagnostic and therapeutic, and enteroscopies, a combination of midazolam and meperidine was the most common sedation method used in colonoscopies and ERCPs (Fig. 1). In the absence of an anesthetist, sedation was controlled in 44% of units by the endoscopist, and in 55% by the endoscopist together with a nurse. At the recovery room, patients were controlled by a nurse in 55.6% of units, by the endoscopist in 11.1%, and by both in 22.2%. Finally, in 11.1% of endoscopy units patients were not controlled at all. No statistically significant differences were found in the previously mentioned variables.

The knowledge for manipulating sedation drugs and their monitoring was acquired through practical experience in 31% of cases, during residence in 68%, from academic courses in 12%, and in other ways in 12% of cases. Besides, 33% of units remembered having had some severe difficulties associated with sedation: breathing depression in two of the units, respiratory arrest in two of the units, and generalized seizures in one of the units.

Desirable sedation level

When questioned about the need for an anesthetist within the unit, 35% of units would like a full time anesthetist for explorations, 35% only under rare circumstances, and finally 35% would not desire one. Finally, specialists considered that some level of sedation was required, as expressed in mean ± standard deviation (SD), in 53.5% (SD ± 30.9%) of diagnostic gastroscopies, in 83% (SD ± 16.1%) of therapeutic gastroscopies, in 80.3% (SD ± 19%) of diagnostic colonoscopies, in 87% (SD ± 17.1%) of therapeutic colonoscopies, in 98% (SD ± 6.9%) of ERCPs, in 95% (SD ± 14.1%) of enteroscopies, and in 98% (SD ± 4.5%) of echoendoscopies. The breakdown of these results considering type of sedation (no sedation, conscious sedation, deep sedation), is shown in figure 2. No statistically significant differences were found in relation with the type of hospital or the complexity of explorations carried out by units.

DISCUSSION

The SGPD inquiry shows that although Galician endoscopy units considered that most patients should be sedated, this is not their usual clinical practice for certain explorations. Several inquiries have evaluated sedation in endoscopy units throughout Europe (7-10). Recently, the result of an inquiry on sedation habits in Catalonia, Spain, has been published as an abstract (11). The methodology used in previously published studies is diverse: anonymous inquiries (8,11), database retrospective revisions (10), and prospective assessment of sedation type (7,9). Our main objective in developing this questionnaire was to know the available resources and the subjective assessment by endoscopists on sedation needs. Several aspects of clinical practice such as type of sedation for each exploration, drugs used, and number of complications need a prospective study to be correctly evaluated. Nevertheless, the results of this inquiry reflect common clinical practice and requirements to sedate, as evaluated by Galician professionals regardless of center ownership, number of endoscopies performed, and complexity.

Although several clinical guidelines and consensus documents have been published with recommendations on the necessary resources to sedate and type of sedation desired for each exploration (3-5), published inquiries show differences between these recommendations and clinical practice. On the other hand, besides a discussion on the need and level of sedation desired for each exploration, it is clear that some minimum resources and basic knowledge are required for a safe management of sedation during endoscopy. In fact, sedation is responsible for between 30 and 50% of human and material costs in diagnostic gastroscopies (12).

Monitorization during the endoscopic procedure allows to detect early evidence of complications such as changes in respiratory function, heart rate, blood pressure, and cardiac electric activity. Although monitorization with electronic devices improves patient assessment, it should not replace clinical control (5). A pulse oximetry may improve control of the respiratory function in patients under sedation and analgesia (13,14). Besides, the administration of oxygen before and during endoscopy reduces desaturation (12). That way monitorization with pulse oximetry as well as oxygen administration is recommended during all endoscopies with sedation (5). In our inquiry, although most units had oxygen available, 20% had no pulse oximeter. This information is in accordance with the inquiry performed by Fasoli et al. on quality parameters in colonoscopies in Northern Italy. In this inquiry, we saw that although 63.9% of endoscopies were performed with sedation, only 44.2% of patients were monitored using pulse oximetry (9). When it comes to electrocardiographic monitoring, it is recommended only in patients with cardiorespiratory conditions, of advanced age, or in prolonged procedures (5). In Galicia, it was only available in 42% of units. We did not ask for any information on other technologies in current evaluation, such as capnography or biespectral monitoring (5). On the other hand, endoscopy units should have the material resources needed to immediately rescue a patient should complications arise (4). In our inquiry, we show that serious deficiencies exist especially regarding lack of defibrillators in most units. Furthermore, we would like to emphasize that only 45% of the inquired units had a recovery room. Therefore, recovery after sedation was carried out at endoscopy rooms in most cases.

There are several controversies on the usefulness of sedation during endoscopic procedures, especially in gastroscopies and diagnostic colonoscopies. Although both procedures may be performed without sedation in most patients (15,16), they are well tolerated in only 59% of gastroscopies (15) and in 61% of diagnostic colonoscopies (17). There are few randomized studies evaluating the usefulness of sedation in these procedures (18-20). In those studies, the improvement in tolerance after premedication was scarce. Factors such as advanced age and lower pharyngeal sensitivity in gastroscopies (15), and sex or a previous enteric resection in colonoscopy (16) are associated with improved tolerance of the procedure without sedation. Our inquiry was not designed to evaluate the rate of procedures performed with sedation. Thus, results are not comparable to those published in the literature. Nevertheless, we have to point out that 63.2 and 45% of units use sedation in less than 50% of gastroscopies and diagnostic colonoscopies, respectively. On the other hand, the rate of units not using sedation in more than 50% of therapeutic or complex procedures lowers widely. However, units answered that gastroscopies and diagnostic colonoscopies should be performed with conscious sedation in 50 and 72% of cases, respectively, and with deep sedation in 3 and 8% of cases, respectively. This rate disagrees with the current clinical practice in our units, probably in relation to the deficient monitoring resources and increased exploration time due to sedation. In a study recently carried out by Campo et al. in Catalonia, Spain, 17% of gastroscopies, 61% of colonoscopies, and 100% of ERCPs were performed with some level of sedation (11). These results are comparable to those of our study.

Both clinical guidelines and consensus documents recommend the use of benzodiazepines, especially midazolam, for conscious sedation during endoscopy (2,3,5). Although data on the benefit of the combined use of benzodiazepines and opioids such as meperidine are contradictory, their use is widespread (7). In our inquiry, while monotherapy with midazolam was the preferred treatment for sedation during gastroscopies and enteroscopies, the combination of midazolam and meperidine was a favorite for colonoscopies and ERCPs. On the other hand, in order to perform a safe sedation, drugs able to rapidly revert effects on the central nervous system are needed. In our inquiry, endoscopy units had benzodiazepine antagonists in a high rate.

In some complex and long procedures, patients benefit from sedation with drugs such as propofol to induce deep sedation (4). Deep sedation has been shown to be superior to conscious sedation in complex endoscopies such as ERCPs. However, deep sedation has little benefit over conscious sedation during routine endoscopy (19). This kind of sedation requires intensive monitoring by a qualified staff. In case of associated increased risk, it must be controlled by an anesthetist (5). In our inquiry, propofol was used in 6% of gastroscopies and therapeutic colonoscopies, and in 10% of ERCPs. On the other hand, although anesthetists are usually available to monitor and control sedation in endoscopy units, none of the units explored had an anesthetist permanently. In fact, 35% of the inquired answered that they wished they could have an anesthetist always in the unit. In the results published as an abstract by Campo et al., an anesthetist was responsible for sedation in 7% of gastroscopies, 25% of colonoscopies, and 38% or ERCPs (11). These results suggest sedation patterns similar to those seen in Galicia.

The practitioner in charge of initiating sedation must have specific training allowing him or her to safely handle the patient during the procedure. He must know the doses and adverse effects, the ways to revert effects, and how to handle monitoring resources. In addition, he or she must be able to safely perform cardiorespiratory resuscitation maneuvers. In our inquiry, most endoscopists had picked their knowledge up during residence or through practice. Practitioners having gone through specific academic courses on sedation techniques were rare. So, endoscopists should have specific training on sedation techniques during residence, and this knowledge should be updated frequently.

To sum it all up, although endoscopy units in Galicia are well-equipped regarding drugs, there are marked deficiencies in monitoring equipment. Besides, the rate of units that do sedate is usually low. However, endoscopists consider that patients should be sedated during endoscopy more often that currently performed. A prospective national study to evaluate the resources available for sedation and the common clinical practice is required. The minimum conditions to sedate patients in endoscopy units, and the necessary mechanisms to guarantee safe sedation should be established as well.

ACKNOWLEDGMENTS

Our thanks go to Dr. Enrique Domínguez Muñoz, Secretary of Sociedad Gallega de Patología Digestiva, for his comments on the manuscript.

REFERENCES

1. Wang T, Lin J, Waye JD. Worldwide use of sedation and analgesia for upper intestinal endoscopy. Sedation for upper GI endoscopy in Taiwan. Gastrointest Endosc 1999; 50 (6): 888-91.        [ Links ]

2. Froehlich F, Schwizer W, Thorens J, Kohler M, Gonvers JJ, Fried M. Conscious sedation for gastroscopy: patient tolerance and cardirespiratory parameters. Gastroenterology 1995; 108: 697-704.         [ Links ]

3. U.K. Academy of Medical Royal Colleges and their Faculties. Implementing and ensuring safe sedation practice for healthcare procedures in adults. Report of a intercollegiate working party chaired by the Royal College of Anaesthetists. Available at: www.aomrc. org.uk. November 2001.        [ Links ]

4. Faigel DO, Baron TH, Goldstein JL, Hirota WK, Jacobson BC, Joahnson JF, et al. Guidelines for the use of deep sedation and general anaesthesia for GI endoscopy. Gastrointest Endosc 2002; 56: 613-7.         [ Links ]

5. Guidelines for conscious sedation and during gastrointestinal endoscopy. Gastrointest Endosc 2003; 58 (3): 317-22.        [ Links ]

6. Ciriza C, García L, Fernández A, Díez A, Delgado M, San Sebastián AI. Sedación en endoscopia digestiva. Análisis de la tolerancia y de las complicaciones. Rev Esp Enferm Dig 2001; 93: 587-92.        [ Links ]

7. Quine MA, Bell GD, McCloy RF, Mathews HR. Prospective audit of upper gastrointestinal endoscopy in two regions of England: safety, staffing and sedation methods. Gut 1995; 36: 462-7.        [ Links ]

8. Daneshmend TK, Bell GD, Logan RFA. Sedation for upper gastrointestinal endoscopy: results of a nationwide survey. Gut 1991; 32: 12-5.        [ Links ]

9. Fasoli R, Repaci G, Comin U, Minoli G; Italian Association of Hospital Gastroenterologists. A multi-centre North Italian prospective survey on some quality parameters in lower gastrointestinal endoscopy. Dig Liver Dis 2002; 34 (12): 833-41.        [ Links ]

10. Mulcahy HE, Hennessy E, Connor P, Rhodes B, Patchett SE, Farthing MJG, et al. Changing patterns of sedation use for routine out-patient diagnostic gastroscopy between 1989 and 1998. Aliment Pharmacol Ther 2001; 15: 217-20.        [ Links ]

11. Campo R, Brullet E, Junquera F, Puig-Divi V, Vergara M, Montserrat A, et al. Sedación y anestesia en endoscopia digestiva. Resultados de una encuesta hospitalaria en Cataluña. Gastroenterol Hepatol 2004; 27 (3): 205.        [ Links ]

12. Mokhashi MS, Hawes RH. Struggling toward easier endoscopy. Gastrointest Endosc 1998; 48: 432-40.        [ Links ]

13. Council on Scientific Affairs, American Medical Association. The use of pulse oximetry during conscious sedation. JAMA 1993; 270: 1463-8.        [ Links ]

14. Bell GD, Bown S, Morden A, Coady T, Logan RF. Prevention of hypoxaemia during upper gastrointestinal endoscopy by means of oxygen via nasal cannulae. Lancet 1987; 1: 1022-4.        [ Links ]

15. Abraham N, Barkun A, LaRocque M, Fallone C, Mayrand S, Baffis V, et al. Prediciting which patients can undergo upper endoscopy comfortably without conscious sedation. Gastrointest Endosc 2002; 56 (2): 180-9.        [ Links ]

16. Ladas SD. Factors predicting the possibility of conducting colonoscopy without sedation. Endoscopy 2000; 32 (9): 688-92.        [ Links ]

17. Cataldo PA. Colonoscoy without sedation: a viable alternative. Dis Colon Rectum 1996; 39: 257-61.        [ Links ]

18. Ristikankare M, Hartikainen J, Heikkinen M, Jantuinen E, Julkunen R. Is routinely given conscious sedation of benefit during colonoscopy? Gastrointest Endosc 1999; 49 (5): 566-72.        [ Links ]

19. Fisher NC, Bailey S, Gibson JA. A prospective, randomized controlled trial of sedation vs no sedation in outpatient diagnostic upper gastrointestinal endoscopy. Endoscopy 1998; 30: 21-4.        [ Links ]

20. Cacho G, Dueñas C, Pérez de las Vacas J, Robledo P, Rosado JL. Viablidad de la colonoscopia sin analgesia y sedación consciente. Gastroenterol Hepatol 2000; 23 (9): 407-11.        [ Links ]