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Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070379
Recruitment Status : Unknown
Verified February 2017 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Esophagogastroduodenoscopy Procedure: Topical lidocaine pharyngeal anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Application of Topical Pharyngeal Anesthesia in the Esophagogastroduodenoscopy Under Sedation
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
Topical lidocaine pharyngeal anesthesia was performed.
Procedure: Topical lidocaine pharyngeal anesthesia
Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.

No Intervention: Control group
No topical lidocaine pharyngeal anesthesia was performed.



Primary Outcome Measures :
  1. Immediate throat pain score [ Time Frame: 1 day ]
    Immediate throat discomfort will be recorded, and pain score (0 no pain - 10 most painful) will be given by the patients.


Secondary Outcome Measures :
  1. Throat discomfort 1 day after the procedure [ Time Frame: 1 day ]
    All the patients will be followed up by telephone 1 day after the endoscopic examination. Throat Discomfort will be recorded.

  2. Adverse events [ Time Frame: 1 day ]
    All the adverse events during the sedated endoscopic examination will be recorded.

  3. Satisfaction score [ Time Frame: 1 day ]
    Patients will give a satisfaction score of 0 (unsatisfied) -10 (very satisfied) based on their own experience.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070379


Contacts
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Contact: Xiaotian Sun, M.D., Ph.D. +86-010-66947473 xiaotian-sun@hotmail.com
Contact: Yang Xu, M.D., Ph.D. +86-010-66947473 yanuoda531@163.com

Locations
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China
Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, China, 100071
Contact: Yan Liu, M.D., Ph.D.    +86-010-66947473    13911798288@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
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Principal Investigator: Yang Liu, M.D., Ph.D. Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT03070379    
Other Study ID Numbers: 307-TA
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action