Introduction
Balanced propofol sedation administered by adequately trained non-anesthesiologist personnel has gained popularity in GI endoscopy because of its shorter procedure and recovery time, high patient satisfaction, and low rate of adverse events (AEs), even if it's still considered controversial. We reported data from a retrospective audit of Endoscopist directed nurse administered sedation (ED-NAAS) over a 2-year period in an Italian referral hospital.
Aims & Methods
Consecutive endoscopic procedures performed between October 2020 and October 2022 were considered. Under the guidance of the endoscopist, the nurse administered 1 to 2mg of midazolam, followed by a progressive top-up dosages of 10-20mg bolus of propofol to achieve moderate to deep sedation. Fentanyl was administred based on the patient's weight if indicated. Endoscopists and nurses were all certified in our hospital with a continuous and scheduled training from 2006. The patients' characteristics, dosage of administered drugs, AEs during and after the examination, were all investigated. The following AEs were deemed minor but significant: bradycardia (≤50 beats/min ≥10 seconds), hypoxia (SaO2 ≤ 90% ≥10 seconds) and hypotension (systolic BP ≤100 mmHg with a drop ≥ 20 mmHg). Major consequences included death, a persistently low state of awareness, permanent harm, the need for an emergency anaesthetist evaluation, the need for hospitalization or endotracheal intubation. To increase the sensitivity of AEs detection, reports were reviewed in these cases: (1)AEs declared in the report, (2)search by string "desaturation" "hypotension" "bradycardia" "apnoea” “hypoxia" in the report, (3)oxygen saturation level, systolic BP and heart rate ≤50 bpm annotated during the intra-procedural monitoring compared to parameters measured before sedation, (4)patients administered flumazenil, naloxone, etilephrine, atropine.
Results
A total of 19407 examinations (7803 EGDS, 10439 colonoscopies, 77 PEG, 697 EUS and 365 ERCP) and 14415 patients were enrolled. 29.4% of patients were classified as ASA I, 66.5% as ASA II and 5.1% as ASA III. Balanced sedation with propofol was administered in 86% of EGDS, 94% of colonoscopies, 92% of EUS, 94% of ERCP and in 72% of PEG. Hypotension was recorded in 1293 (6%) examination, which required fluid infusion in 330 cases (26%) and in 8 cases etilephrine to restore blood pressure. Bradycardia was recorded in 176 (0.9%) patients, which required atropine in 134 (72.8%) cases. 11 patients (0.06 %) had a minor respiratory adverse event. The mean age of patients of hypotension, bradycardia and respiratory adverse event was respectively 61.1±15 years, 64.3±15.3 and 55.6±16.2. ASA III patients were respectively 4.1%, 2.8% and 27.2% in the three groups of AEs. The mean SD/median (25th-75th percentil) dosage of medications were respectively 2.0±0.7mg, 2.0±0.7mg, 1.8±0.3mg of midazolam, 71.0±34.5mcg, 68.0±31.0mcg and 62.5±9.5mcg of fentanyl, 94.0±74.3mg, 77.0±61.7mg and 120 (70-190)mg of propofol. BMI and Mallampati score of II were respectively 23.0±4.5 and 72.8% in patients with respiratory AEs. 1 patient (0.001%) had a major AE, needing oro-tracheal intubation. He was 63 years old with unknown diagnosis of amyotrophic lateral sclerosis, with normal BMI, Mallampati score I, sedated with 2mg of midazolam + 80mg of propofol. Limits of the study include recall bias (missed cases of AEs not caused by sedation but because of examination itself, e.g., bradycardia or laryngospasm).
Conclusion
Balanced propofol ED-NAAS is safe in low-risk patients. Major adverse events occurred in 0.001% procedures.
