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Original article Clinical endoscopy: Editorial| Volume 93, ISSUE 1, P209-211, January 2021

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Endoscopist-administered propofol sedation during colonoscopy: Time to take over the syringe?

      Abbreviation:

      NAAP (nonanesthesiologist-administered propofol sedation)
      The objectives of colonoscopy are to perform optimal mucosal inspection in a safe and effective manner. Patient sedation is key to this goal. Not all patients will require sedation during colonoscopy,
      • Ladas S.D.
      Factors predicting the possibility of conducting colonoscopy without sedation.
      but for a significant number, or for those requiring longer therapeutic procedures, sedation is necessary. The ideal sedative for colonoscopy relieves the patient’s anxiety and discomfort, improves the ability to perform mucosal inspection and therapy, and reduces or eliminates the patient’s memory of the procedure.
      Several of different sedatives and analgesics can be used to achieve appropriate levels of sedation at colonoscopy, ranging from conscious sedation with benzodiazepines and opioids to deep sedation with propofol and general anesthesia. Interestingly, neither the American nor the European guidelines addressing quality indicators for colonoscopy mention the type or amount of sedation that should be given at colonoscopy.
      • Rex D.K.
      • Schoenfeld P.S.
      • Cohen J.
      • et al.
      Quality indicators for colonoscopy.
      ,
      • Kaminski M.F.
      • Thomas-Gibson S.
      • Bugajski M.
      • et al.
      Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative.
      In the West, minimal and moderate sedation regimens for colonoscopy typically consist of a benzodiazepine to minimize anxiety and a narcotic analgesic to minimize pain and discomfort. For benzodiazepines, most endoscopists favor midazolam for its fast onset of action, short duration of action, lower risk of thrombophlebitis, and high amnestic properties.
      • Vargo J.J.
      • DeLegge M.H.
      • Feld A.D.
      • et al.
      Multisociety sedation curriculum for gastrointestinal endoscopy.
      Opiates, such as meperidine and fentanyl administered intravenously, provide both analgesia and sedation. Fentanyl has a more rapid onset of action and clearance and has a lower incidence of nausea compared with meperidine. After sedation, extended recovery room monitoring is necessary to avoid postdischarge sedation-related issues.
      Propofol sedation has been associated with improved patient satisfaction, shorter sedation times, and shorter recovery times when compared with the combination of an opioid and benzodiazepine. This, in addition to its excellent safety profile, supports its use in routine sedation regimens.
      • Early D.S.
      • Lightdale J.R.
      • Vargo J.J.
      • et al.
      ASGE Standards of Practice Committee
      Guidelines for sedation and anesthesia in GI endoscopy.
      The main drawback preventing its wider adoption is the requirement for it to be given by an anesthesiologist in most countries.
      Anesthesiologist-delivered propofol-based sedation constitutes a sizeable proportion of sedation for outpatient endoscopic procedures, particularly in the United States.
      • Khiani V.S.
      • Soulos P.
      • Gancayco J.
      • et al.
      Anesthesiologist involvement in screening colonoscopy: temporal trends and cost implications in the Medicare population.
      The advantages of this approach include decreased distraction for the endoscopist and optimal treatment of patients with medical comorbidities.
      • Tetzlaff J.E.
      • Vargo J.J.
      • Maurer W.
      Nonoperating room anesthesia for the gastrointestinal endoscopy suite.
      ,
      American Society of Anesthesiology
      Statement on anesthesia care for endoscopic procedures 2014.
      However, recent large population-based studies found a higher risk of aspiration in patients receiving deep sedation with propofol as administered by anesthesiologists when compared with patients who received lighter sedation as administered by endoscopists.
      • Cooper G.S.
      • Kou T.D.
      • Rex D.K.
      Complications following colonoscopy with anesthesia assistance: a population-based analysis.
      ,
      • Vargo J.J.
      • Nikliewski P.J.
      • Williams J.L.
      • et al.
      Patient safety by anesthesia professionals during routine upper endoscopy and colonoscopy: an analysis of 1.38 million procedures.
      Additionally, a recent study found a higher perforation rate in colonoscopies performed with the support of anesthesiologists.
      • Wernli K.J.
      • Brenner A.T.
      • Rutter C.M.
      • et al.
      Risks associated with anesthesia services during colonoscopy.
      Perhaps the most significant disadvantage of anesthesia-delivered propofol sedation is the high financial burden. In a cost-effectiveness model, Hassan et al
      • Hassan C.
      • Rex D.K.
      • Cooper G.S.
      • et al.
      Endoscopist-directed propofol administration versus anesthesiologist assistance for colorectal cancer screening: a cost-effectiveness analysis.
      showed that endoscopist-directed propofol sedation (non-anesthesiologist-administered propofol sedation [NAAP]) was more cost effective than anesthesiologist-administered propofol sedation. No significant difference in the adenoma detection rate between endoscopist-directed or anesthesiologist-directed sedation has been found.
      • Dominitz J.A.
      • Baldwin L.M.
      • Green P.
      • et al.
      Regional variation in anesthesia assistance during outpatient colonoscopy is not associated with differences in polyp detection or complication rates.
      Furthermore, extensive data support the safety and efficacy of NAAP.
      • Rex D.K.
      • Heuss L.T.
      • Walker J.A.
      • et al.
      Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy.
      ,
      • Sieg A.
      • Beck S.
      • Scholl S.T.
      • et al.
      Safety analysis of endoscopist-directed propofol sedation: a prospective, national multicenter study of 24 441 patients in German outpatient practices.
      Because of the increased risk of respiratory depression, hypotension, and bradycardia, NAAP requires specialized training for the endoscopist, careful patient selection, and personnel dedicated to continuous physiologic monitoring with expertise in emergency airway management.
      Kim et al
      • Kim D.B.
      • Kim J.S.
      • Huh C.W.
      • et al.
      Propofol compared with bolus and titrated midazolam for sedation in outpatient colonoscopy: a prospective randomized double-blind study.
      performed a randomized, double-blind, prospective study comparing bolus administration of midazolam with titrated administration of midazolam or propofol (NAAP, delivered by endoscopists) during outpatient colonoscopy in a single tertiary-care center among expert endoscopists. In total, 267 patients were enrolled and assigned to the propofol (n = 89), bolus administration of midazolam plus meperidine (n = 89), or titrated administration of midazolam plus meperidine (n = 89) groups. There were no significant differences in baseline characteristics between the groups, or in dose per unit weight between the bolus and titrated midazolam groups.
      The propofol group had a significantly shorter total procedure time than the bolus and titrated midazolam groups (39.5 minutes, 59.4 minutes, and 58.1 minutes; P < .001). Induction time (4.6 minutes vs 6.3 minutes vs 7.6 minutes; P < .001) was also significantly shorter. Patients sedated with propofol required less time to fully recover from the procedure (11.5 minutes vs 29.5 minutes vs 29.2 minutes; P < .001) and were discharged sooner from the endoscopy unit after full recovery (20.6 minutes vs 34.9 minutes vs 34.7 minutes; P < .001). There was no significant difference in sedation-related adverse events (bradycardia, tachycardia, hypotension, or desaturation) between the groups. Patient satisfaction was significantly higher in the propofol group (P < .01), mainly related to reduced appreciation of pain during the procedure. In the assessment of the degree of sedation, more than half of the patients in the propofol group rated this as being “adequate,” whereas most patients in the bolus and titrated midazolam groups reported it to be “excessive,” probably because of the persistent, unwanted effects of midazolam.
      Therefore, the results of this well-conducted, prospective randomized study suggest that propofol sedation during colonoscopy leads to increased patient satisfaction scores, decreased recovery times, and decreased time to leaving the hospital as compared with a midazolam-based regimen, regardless of how that regimen is delivered. Critically, sedation-related adverse events were no different between the groups, suggesting that with adequate training endoscopists can safely deliver propofol-based sedation as they commonly do midazolam-based regimens.
      The findings here that NAAP is safe and results in better outcomes for patients confirm those of previous studies. Two randomized controlled trials compared NAAP for colonoscopy with a combination regimen of midazolam and fentanyl
      • Ulmer B.J.
      • Hansen J.J.
      • Overley C.A.
      • et al.
      Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists.
      and midazolam plus meperidine.
      • Sipe B.W.
      • Rex D.K.
      • Latinovich D.
      • et al.
      Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists.
      All studies found that NAAP exhibited significantly shorter recovery times. There were no significant differences across sedation regimens in the incidence of bradycardia, hypotension, hypoxemia, physician satisfaction, or the number of patients reporting pain or discomfort. Patient satisfaction across all controlled trials was lower with midazolam plus narcotic when compared with monopropofol sedation.
      Where the study of Kim et al
      • Kim D.B.
      • Kim J.S.
      • Huh C.W.
      • et al.
      Propofol compared with bolus and titrated midazolam for sedation in outpatient colonoscopy: a prospective randomized double-blind study.
      breaks new ground is in demonstrating the superiority of propofol compared with midazolam given as a bolus. This was important to demonstrate, after a recent retrospective study in which bolus administration of midazolam and fentanyl was compared with titrated administration, showing a shortened induction time, improved safety, and decreased amount of sedatives required in the bolus administration group.
      • Finn 3rd, R.T.
      • Boyd A.
      • Lin L.
      • et al.
      Bolus administration of fentanyl and midazolam for colonoscopy increases endoscopy unit efficiency and safety compared with titrated sedation.
      A major criticism of the study by Kim et al
      • Kim D.B.
      • Kim J.S.
      • Huh C.W.
      • et al.
      Propofol compared with bolus and titrated midazolam for sedation in outpatient colonoscopy: a prospective randomized double-blind study.
      is the absence of a group of patients receiving no sedation at all. Increasingly accepted, unsedated diagnostic colonoscopy may be particularly suitable for men, patients who are not anxious, patients without a history of abdominal pain, and older patients.
      • Ladas S.D.
      Factors predicting the possibility of conducting colonoscopy without sedation.
      This approach comes with significant advantages: no need for extended recovery room monitoring, minimizing costs, and making it possible for the patient to perform normal daily tasks directly after the procedure, eg, driving themselves home, or working.
      Other limitations of the study include the fact that it was conducted in a single center, with colonoscopies performed only by highly experienced endoscopists. Therefore, the results may not be directly applicable to endoscopists working outside such an environment. Furthermore, as the authors suggest, it cannot have been possible to achieve complete endoscopist blinding to the sedative agent in use.
      The major barrier to further adoption of NAAP in the Western world is regulation that prevents anyone other than an anesthesiologist from administering propofol. Such regulation is determined nationally, so gastroenterology or endoscopy societies will need to take lobbying forward at this level with anesthesiology and regulatory authorities. Adequate training programs for endoscopists and trained registered nurses (whose sole responsibilities are patient monitoring and administration of propofol) will be critical to gain acceptance. Additionally, it will be necessary to rigorously define the parameters within which NAAP may be delivered, including patient-specific risk factors for sedation, the planned depth of sedation, and the urgency and type of endoscopic procedure performed. Currently, NAAP is routinely practiced only in a minority of European countries, the largest of which is Germany. Citing the experience of such countries,
      • Sieg A.
      • Beck S.
      • Scholl S.T.
      • et al.
      Safety analysis of endoscopist-directed propofol sedation: a prospective, national multicenter study of 24 441 patients in German outpatient practices.
      and a published curriculum for sedation training,
      • Dumonceau J.M.
      • Riphaus A.
      • Beilenhoff U.
      • et al.
      European curriculum for sedation training in gastrointestinal endoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA).
      may be of use in convincing regulatory authorities to allow the adoption of NAAP.
      So, where now for sedation in colonoscopy? For diagnostic procedures, discussion with the patient regarding an unsedated procedure should be undertaken because this offers the ability for them to return to normal activity the same day. If sedation is desired or required, overwhelming evidence supports the safety and cost-effectiveness of NAAP and the improved experience of colonoscopy it delivers for patients over midazolam-based regimens. Endoscopists in countries where NAAP is currently prohibited must engage with our anesthesia colleagues over this issue as a matter of urgency. Clear definitions of which patients (eg, comorbidity, therapeutic versus diagnostic procedures) are suitable for NAAP may help to assuage the majority of anesthesiologists’ concerns and ensure safety moving forward.

      Disclosure

      All authors disclosed no financial relationships.

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