This Invited Commentary accompanies the following article:
Hinkelbein J, Lamperti M, Akeson J, et al. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol 2018; 35: 6–24
In recent years, there has been a worldwide increase in demand for procedural sedation and analgesia (PSA) driven by an increasing number of minimally invasive diagnostic and therapeutic procedures. All this has been facilitated by the availability of potent short-acting analgesic and sedative drugs required to make a painful or at least unpleasant experience tolerable, and also by the perception that these drugs are easily managed even by non-anaesthesiologists.
In 2007, the European Board of Anaesthesiology (EBA) of the European Union of Medical Specialists published a ‘guideline for sedation and/or analgesia by non-anaesthesiology doctors’,1 to offer a standard framework of well tolerated care in a setting of increased demand of PSA that, in 2007, was coincident with a shortage of anaesthesiologists in the majority of European countries.
In 2010, fire was put to the powder when the European Society of Gastrointestinal Endoscopy, the European Society of Gastroenterology and Endoscopy Nurses and Associates and the European Society of Anaesthesiology (ESA) published guidelines on the use of propofol for gastrointestinal endoscopy by non-anaesthesiologists.2 Following their publication, a majority of the European National Anaesthesiologists Societies (NAS) expressed their reservations about these guidelines.3 Subsequently, official representatives of the ESA attempted to put the guidelines and their implications into context.4 Despite their efforts, at the ESA general assembly held in Amsterdam on 15 June 2011, a majority of ESA members voted for a motion to retract the endorsement of these guidelines by the ESA.5 At this time, following a discussion at the ESA council meeting, the ESA Board of Directors suggested to the ESA Guidelines Committee that it should evaluate the feasibility of new joint ESA and EBA Guidelines on PSA. Following this request, the ESA Guidelines Committee and the EBA created a PSA guidelines task force.
Ever since, with three aims in mind, the ESA/EBA task force has worked hard to make progress. The first was to address the heterogeneity of PSA practice throughout Europe on a strongly scientific and mostly evidence-based foundation. The second was to seek a balanced position able to accommodate different medical practices, reimbursement policies and political inclinations, and the third was to promote standardisation of training and practice of PSA to the benefit of patient care, enhancing safety standards, particularly for those countries where PSA was already provided by non-anaesthesiologists.
The joint ESA/EBA guidelines on PSA, published in this issue of the European Journal of Anaesthesiology,6 is a document that emphasises the scientific elements. In the course of its preparation it successfully followed and passed all the ESA rules for guideline development.7 The literature search and analysis were painstakingly conducted by the joint ESA/EBA task force. Where there was insufficiently clear and concordant evidence on a specific topic, the Rand Appropriateness Method with three rounds of Delphi voting was used. Following this, the guidelines underwent an external reviewing process and were posted on the ESA website for 30 days for comments. In addition, a prepublication consultation process was extended to the NAS members of the EBA and of the ESA National Anaesthesiology Societies Committee.
The EBA asked its delegates whether they would agree (or otherwise) if this document was endorsed by the EBA. In the event, the majority of the NAS chose to endorse the guidelines. Many of them provided detailed and valuable suggestions for improving the original document. The ESA/EBA task force collated all comments, suggestions and views, and used the majority of them to refine and improve the guidelines. However, it should be noted that to keep the emphasis on the scientific elements it was not possible to include all the comments received. The preservation of anaesthesiologists’ professional/financial interests was outside the scope of the PSA guidelines, but the granting of privileges for well tolerated sedation on a sound scientific foundation was considered a unique opportunity to show leadership in promoting a safer practice of PSA.
When the ESA/EBA task force began to develop the PSA guidelines it very quickly became clear that beyond the scientific and methodological aspects, there would be political implications. This was no surprise of course. The present-day heterogeneity of regulatory constraints in different European countries; the structure of the workforce of anaesthesia teams (certified anaesthesia nurses in some countries but not in others) and the pressure from non-anaesthesiology professionals to perform PSA independently from the anaesthesia teams in some but not all countries, are just a few of the factors that explain the difficult political aspects of PSA guidelines. More subtle problems are linked to financial issues that are not explicitly mentioned but may constitute an incentive to oppose any Pan-European attempt to homogenise the practice of PSA.
Producing a set of guidelines applicable to all European NAS proved to be quite complicated but it was rendered possible because of close collaboration among ESA, EBA and NAS. It is perfectly possible that the guidelines will come into conflict with the aims and constitutions of some NAS. With these, as for all other guidelines, it remains the responsibility of each NAS and other national regulatory bodies to consider their adoption, in whole or in part, because the ESA and EBA have no authority in this field.
The members of the task force who developed the PSA guidelines were aware of these political difficulties, but they considered that there were common elements in the practice of PSA that would bend the balance in favour of their development. What are those common elements? The most important is patient safety, as the literature clearly demonstrates that PSA in high-risk (but also in low risk) patients may be associated with severe side-effects. To achieve the highest level of patient safety, the PSA guidelines must include some mandatory requirements:
- The personnel providing PSA must be trained in all domains: clinical skills, pharmacology of sedative/analgesic drugs, monitoring, prevention, early recognition and prompt treatment of complications;
- The professional who is in charge of PSA for a given patient must have a single task, to exclusively provide sedation/analgesia. This is a critical element because no monitoring device can replace human observation, anticipation and analysis of complex situations;
- The organisational aspects must ensure that, in the location where PSA is provided, there is proximity to facilities and teams that can promptly provide well tolerated resuscitation, and can oversee the elimination of sedative drugs and full recovery of vital functions;
- The identification of a subset of high-risk patients and complex clinical situations where PSA MUST be provided ONLY by anaesthesia professionals.
The PSA guidelines task force chose not to provide too many details on the pharmacology of the drugs used for PSA mainly because it is nearly impossible from the present-day literature to assert that one drug or class of drugs is better than another. The task force considered that beyond solid knowledge of the pharmacology of individual drugs, the choice of a drug or combination of drugs for an individual must be based on detailed knowledge of comorbidities and the constraints of the procedure and adapted to clinical reality. The task force also considered that by not choosing the ‘best drug’ it would avoid indiscriminate use by non-anaesthesia professionals of ‘recipes’ without proper knowledge of pharmacology.
It may be that, by providing a list of mandatory safety requirements, we make the provision of PSA by non-anaesthesia professionals seem a straightforward matter. This belies the fact that to provide PSA to the level of expertise required and to overcome the organisational constraints poses a huge challenge to non-anaesthesia professionals. One final consideration was that the members of the PSA guidelines task force made it mandatory that patients were informed exactly who was in charge of PSA and what was their status. So, although laid out in strict terms, the ESA/EBA PSA guidelines do not close the door to the provision of PSA by non-anaesthesia professionals but they do set an evidence-based safety standard that is very high in order to reach zero preventable complications.
Acknowledgement related to this article
Assistance with the invited commentary: none.
Financial support and sponsorship: EDR has participated in educational programs and received speaker's fees of Masimo and MSD; DL has received grants and funding from LFB (France), Baxter International (USA), Fresenius Kabi (Germany), and he has participated in educational programs and has received speaker's fees from Masimo, Medtronic, Edwards Laboratories and Orion Pharma. TFB has received honoraria for lectures from MSD.
Conflicts of interest: EDR, DL and TFB have participated in the development and publication of the European Society of Anaesthesiology (ESA) and European Board of Anaesthesiology (EBA) guidelines for procedural sedation and analgesia in adults; TFB has acted as the chairperson of the expert panel. EDR is the chair of the ESA Guideline Committee and a member of the European Board of Anaesthesiology (EBA/UEMS). DL is a member of the Board of Directors of the European Society of Anaesthesiology and Chairperson of the National Anaesthesiologists Societies Committee (NASC) of the European Society of Anaesthesiology.
Comment from the editor: this invited commentary was checked and accepted by the editors but was not sent for external peer review. TFB is an Associate Editor of the European Journal of Anaesthesiology.
1. Knape J, Adriansen H, van Aken H, et al. Board of Anaesthesiology of the European Union of Medical Specialists. Guidelines for sedation and/or analgesia by non-anaesthesiology doctors. Eur J Anaesthesiol
2. Dumonceau JM, Riphaus A, Aparicio JR, et al. NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol
3. Perel A. Non-anaesthesiologists should not be allowed to administer propofol for procedural sedation: a Consensus Statement of 21 European National Societies of Anaesthesia. Eur J Anaesthesiol
4. Werner C, Smith A, Van Aken H. Guidelines on non-anaesthesiologist administration of propofol for gastrointestinal endoscopy: a double-edged sword. Eur J Anaesthesiol
5. Pelosi P. Board of the European Society of Anaesthesiology. Retraction of endorsement: European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates and the European Society of Anaesthesiology Guideline: non-anaesthesiologist administration of propofol for gastrointestinal endoscopy. Eur J Anaesthesiol
6. Hinkelbein J, Lamperti M, Akeson J, et al. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol
7. De Robertis E, Longrois D. To streamline the guideline challenge: the European Society of Anaesthesiology policy on guidelines development. Eur J Anaesthesiol