Clinical trial NCT03070379: Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy
Official title: The Application of Topical Pharyngeal Anesthesia in the Esophagogastroduodenoscopy Under Sedation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagogastroduodenoscopy
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At recent, the number of patients who underwent sedated esophagogastroduodenoscopy has been on the increase. For such patients, whether topical pharyngeal anesthesia is needed remains to be controversial. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline for non-anesthesiologist administration of propofol for GI endoscopy have not made any recommendation, because the role of pharyngeal anesthesia during propofol sedation for upper digestive endoscopy has not been assessed. Our study aimed at investigating whether topical lidocaine pharyngeal anesthesia could benefit patients who underwent esophagogastroduodenoscopy under propofol sedation.

Detailed description: Propofol sedation has been widely applied in endoscopic examinations. For such patients, whether lidocaine topical pharyngeal anesthesia should be administrated is still in doubt. Considering the fact that lidocaine anesthesia may cause airway narrowing and anaphylaxis, it is important to clarify the role of lidocaine topical pharyngeal anesthesia in esophagogastroduodenoscopy under propofol sedation. Our study could test whether lidocaine topical pharyngeal anesthesia should be performed in sedated esophagogastroduodenoscopy in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 Years
* Patients who have indications for esophagogastroduodenoscopy
* American Society of Anesthesiology risk class 1, 2 or 3

Exclusion Criteria:

* Patients \<18 years
* Patients with thrombocytopenia (platelet count \< 50,000/microL) or elevated International Normalized Ratio (INR \> 1.5)
* Hemodynamic instability
* Pregnancy and lactation
* Patients who are unable or unwilling to give an informed consent

Primary outcomes:
measure: Immediate throat pain score
timeFrame: 1 day
Secondary outcomes:
measure: Throat discomfort 1 day after the procedure
timeFrame: 1 day
measure: Adverse events
timeFrame: 1 day
measure: Satisfaction score
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital to Academy of Military Medical Sciences
Study officials:
affiliation: Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
name: Yang Liu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.
citation: Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; 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. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
citation: Sun X, Xu Y, Zhang X, Li A, Zhang H, Yang T, Liu Y. Topical pharyngeal anesthesia provides no additional benefit to propofol sedation for esophagogastroduodenoscopy: a randomized controlled double-blinded clinical trial. Sci Rep. 2018 Apr 27;8(1):6682. doi: 10.1038/s41598-018-25164-7.