Clinical trial NCT02307773: Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy
Official title: Does Use of Lidocaine Spray on an Endoscope Immediately Before Insertion Improve Patient Tolerance to Endoscopy? A Single Center, Case-Control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: C.Medical Procedure; Digestive System
Disorder of Upper Gastrointestinal Tract
Tolerance
Keywords: Upper Gastrointestinal Endoscopy
Pharyngeal Anesthesia
Lidocaine
Belching
Retching
Tolerance
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 497
Sex: ALL
Minimum age (years): 16
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room 2, Digestive Disease Center, Halla General Hospital, Jeju, Korea were enrolled consecutively during Nov. 4 2013 - May 7 2014.

Brief summary: The investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone.

Detailed description: All the patients underwent upper gastrointestinal endoscopy were consecutively enrolled and assigned to case group treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation or control group with conventional pharyngeal anesthesia without further treatment. And the investigators compared their baseline characteristics, past history, sedation or not, and frequency of retching and belching were measured during the endoscopy.

Eligibility criteria: Inclusion Criteria:

* All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room, Cheju Hall General Hospital.

Exclusion Criteria:

* advanced older or younger age (\> 90, or \< 15 years)
* comorbidities scored greater than III of American Society of Anestheiologists Physical Status Classification System (ASA) score
* history of hypersensitivity reaction to lidocaine
* he pregnant
* therapeutic or emergency endoscopy

Primary outcomes:
measure: Frequency of Belching and retching
timeFrame: Participants will be followed for the duration of hospital stay, expected average of 1-2 hours
Secondary outcomes:
measure: Adverse events
timeFrame: Participants will be followed for the duration of hospital stay, expected average of 1-2 hours
Other outcomes:
Locations:
city: Jeju-si
country: Korea, Republic of
facility: Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital
state: Jeju Special Self-Governing Province
Study officials:
affiliation: Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea
name: Byung Hyo Cha, M.D.
role: PRINCIPAL_INVESTIGATOR
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