Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial.
Author(s): Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L
Affiliation(s): Department of Internal Medicine, Zollikerberg Hospital, Zurich, Switzerland.
Publication date & source: 2011-12, Gastrointest Endosc., 74(6):1207-14. Epub 2011 Oct 13.
BACKGROUND: In patients undergoing routine upper EGD, propofol is increasingly used without pharyngeal anesthesia because of its excellent sedative properties. It is unclear whether this practice is non-inferior in regard to ease of endoscopic intubation and patient comfort. OBJECTIVE: To assess the relevance of local pharyngeal anesthesia regarding the ease of EGD performance in patients sedated with propofol as monotherapy. DESIGN: Randomized, double-blind, placebo-controlled, non-inferiority trial. SETTING: One community hospital and one university hospital in Switzerland. PATIENTS: We enrolled 300 consecutive adult patients undergoing elective EGD. INTERVENTION: Pharyngeal anesthesia with 4 squirts of lidocaine spray versus placebo spray immediately before propofol sedation. MAIN OUTCOME MEASUREMENTS: Number of gag reflexes (primary endpoint), number of intubation attempts, and degree of salivation during intubation (secondary endpoints) assessed by the endoscopists and staff. RESULTS: In the lidocaine group, 122 patients (82%) had no gag events, and 25 patients had a total of 39 gag events, whereas in the placebo group 104 patients (71%) had no gag events, and 43 patients had a total of 111 gag events. The rate ratio of gagging with quasi-likelihood estimation of placebo compared with lidocaine was 2.85 (95% confidence interval [CI], 1.42-6.19; P = .005). In adjusted logistic regression analysis, the odds ratio for gagging for placebo pharyngeal anesthesia compared with lidocaine was 1.9 (95% CI, 1.03-3.54). The number of intubation attempts and the degree of salivation were similar in both groups. Two patients in the placebo group experienced oxygen desaturation and needed short-term mask ventilation. LIMITATIONS: The level of sedation and possible long-term side effects of pharyngeal anesthesia were not assessed. CONCLUSION: Topical pharyngeal anesthesia reduces the gag reflex in patients sedated with propofol even though it does not seem to have an influence on the ease of the procedure and on patient or endoscopist satisfaction in adequately sedated patients. (Clinical trial registration number: NCT01081002.). Copyright (c) 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.