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Revista Española de Enfermedades Digestivas

versión impresa ISSN 1130-0108

Rev. esp. enferm. dig. vol.97 no.1 Madrid ene. 2005




Who should be responsible for sedation techniques in digestive endoscopy?


MOTTO: "Your truth? No, the truth, and come with me to seek it; keep yours to yourself."
Antonio Machado


The increased number and frequency of anesthetic procedures outside the surgical domain, the introduction of novel technologies, pharmacological advances (safer anesthetics with a faster clearance), and social demands have all raised anesthesiologists' needs not only in Spain but throughout Europe.

However, our deficiency in specialists of anesthesiology and resuscitation, and the belief that sedation techniques are risk-free, do not warrant the fact that such techniques be performed by non-anesthesiologists, that these specialists may concurrently perform sedation and an endoscopic procedure, or that sedation be carried out by non-medical staff.

Every medical activity has to ensure excellent quality, safety and study, cost/benefit, and cost/efficiency.

Of note, those responsible for examinations entailing more or less "invasive" procedures pose no problems in cooperating with anesthesiologists, and such is the case, for instance, with interventionist radiology, hemodynamics, etc.

Problems virtually only arise in the setting of digestive endoscopy, as this technique is erroneously considered a procedure with minor risk. In the past few years technological innovation has been multiple and ceaseless in the field of endoscopy. Endoscopy Units have -to a lesser or greater extent- adjusted to their new equipments and techniques, which has required continuous effort and commitment from healthcare authorities involved. However, this has not been paralleled by an adjustment to sedation needs, which are increasingly higher regardless of the Unit's level. "Ad-hoc" rooms for sedation are hard to come across, regarding both their design and the integration of qualified specialists in charge. Responsibility for their absence should rest with a Center's Board of Directors, not the Unit's managers, provided these warrant their inclusion in the planning of the Unit's needs. This forces departments of anesthesiology and resuscitation to be efficient in combining both material and staff resources in order to meet adequate safety and quality guidelines, and hence provide the optimal care every patient is entitled to.

All these aspects have obvious legal connotations to be born in mind, some of which follow:

-Since sedation techniques are procedures entailing a certain risk, it is particularly important that an informed consent be obtained.

It is a well-known fact that voluntariness is the rule regarding healthcare treatments, and this voluntariness is mainly specified in Law 41/2002 of November 14, the Basic Regulatory Law on Patient Autonomy and Patient Rights and Duties Regarding Clinical Information and Documentation.

-There is much controversy regarding which healthcare provider -and with what qualifications- should perform sedation techniques.

A number of reports in other countries agree that the person in charge of sedation, to ensure optimal quality and safety for patients, should meet a minimum set of requirements.

Various organizational models may be found in the medical literature, as well as a number of anesthetic protocols or guidelines for sedation and/or analgesia procedures.

Protocols issued by the American Society of Anesthesiology (ASA) recommend that a professional different from that carrying out the endoscopic technique be present to monitor the patient, his or her vital signs, and anesthetic depth. As of 1991 it was recommended that the person responsible for monitoring the patient and sedation must be a physician. Other papers demand that all medical staff be trained in both basic and advanced cardiopulmonary resuscitation techniques, and that patient inclusion should be restricted to ASA I or II individuals with no difficulties regarding airway management. Along the same lines ASA recommends that patients receiving sedation with propofol be monitored by someone able to "rescue" them from general anesthesia.

ASA has established that anesthetic care for outpatient procedures must follow general standards; this includes the permanent presence of an anesthesiologist during surgical procedures whenever general or regional anesthesia, or sedation with or without analgesia, is required in such a way that loss of airway reflexes may be reasonably expected. Similarly, ASA has established that this be accomplished for both surgical and non-surgical (diagnostic, therapeutic) procedures with a physiologic impact and likely to put patients at risk regardless of anesthesia.

In 1995, SEDAR published their "Clinical Practice Guide for Anesthesiology and Resuscitation" as a reflection of this Society's criteria, which includes a set of specific recommendations in relation to basic diagnostic methods and procedures in clinical anesthesiology that are applicable to patients with ASA I (American Society of Anesthesiology) risk, and establishes basic (intraoperative) monitoring criteria such as non-invasive blood pressure, ECG, and oxygen saturation (pulse oximetry). It also mentions the minimum requirements of appropriate postanesthetic care for patients undergoing a variety of anesthetic procedures, the so-called monitored anesthetic surveillance.

In view of this information, consensus exists on the fact that specialists in anesthesiology and resuscitation should perform these techniques.

-A demand that sedation procedures be carried out by a specialist in anesthesiology and resuscitation.

A specialist in anesthesiology and resuscitation should carry out anesthetic procedures (sedation) in compliance with the "lex artis ad hoc" principle. Absence of a specialist degree may not only result in a violation of "lex artis ad hoc" -and hence in civil liability- but also in criminal liability.

Obviously in this scenario, healthcare professionals who either on their own initiative or "following instructions issued by a center's board of directors" carry out anesthetic techniques lacking an appropriate degree and specific professional knowledge to perform said techniques commit a criminal deed of professional intrusion, as typified in Art. 403 under the criminal law in force.

In short, in order to guarantee the patient's right to health it should be demanded that sedoanalgesia (conscious sedation) and deep sedation techniques be exclusively performed by professionals with appropriate qualifications and training for their diligent execution, which is only the case with physicians who are specialists in anesthesiology and resuscitation.

By the way, who do patients think should perform sedation?

F. López Timoneda and J. A. Ramírez Armengol1

Service of Anesthesiology, Reanimation and Pain. 1Service of Endoscopy.
Hospital Clínico San Carlos. Madrid, Spain



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