Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

Affiliated Hospital to Academy of Military Medical Sciences

Status: Unknown

Conditions: Esophagogastroduodenoscopy

Treatments: Procedure: Topical lidocaine pharyngeal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03070379

307-TA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Experimental group

Experimental group

Description:

Topical lidocaine pharyngeal anesthesia was performed.

Treatment:

Procedure: Topical lidocaine pharyngeal anesthesia

Control group

No Intervention group

Description:

No topical lidocaine pharyngeal anesthesia was performed.