Esophagogastroduodenoscopy
Conditions
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.
Interventions
PROCEDURETopical lidocaine pharyngeal anesthesia
Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate throat pain score | 1 day | Immediate throat discomfort will be recorded, and pain score (0 no pain - 10 most painful) will be given by the patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Throat discomfort 1 day after the procedure | 1 day | All the patients will be followed up by telephone 1 day after the endoscopic examination. Throat Discomfort will be recorded. |
| Adverse events | 1 day | All the adverse events during the sedated endoscopic examination will be recorded. |
| Satisfaction score | 1 day | Patients will give a satisfaction score of 0 (unsatisfied) -10 (very satisfied) based on their own experience. |
Countries
China
Contacts
Primary ContactXiaotian Sun, M.D., Ph.D.
Backup ContactYang Xu, M.D., Ph.D.
Outcome results
None listed