Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

Esophagogastroduodenoscopy Clinical Trial

Official title:

The Application of Topical Pharyngeal Anesthesia in the Esophagogastroduodenoscopy Under Sedation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070379
• Other study ID #: 307-TA
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: March 2, 2017
• Start date: February 20, 2017
• Est. completion date: May 2017

Study information

• Verified date: February 2017
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Xiaotian Sun, M.D., Ph.D.
• Phone: +86-010-66947473
• Email: xiaotian-sun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagogastroduodenoscopy

Intervention

Procedure:
• Topical lidocaine pharyngeal anesthesia
Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate throat pain score	Immediate throat discomfort will be recorded, and pain score (0 no pain - 10 most painful) will be given by the patients.	1 day
Secondary	Throat discomfort 1 day after the procedure	All the patients will be followed up by telephone 1 day after the endoscopic examination. Throat Discomfort will be recorded.	1 day
Secondary	Adverse events	All the adverse events during the sedated endoscopic examination will be recorded.	1 day
Secondary	Satisfaction score	Patients will give a satisfaction score of 0 (unsatisfied) -10 (very satisfied) based on their own experience.	1 day