Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy

NCT ID: NCT02307773

Last Updated: 2015-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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C.Medical Procedure; Digestive System Disorder of Upper Gastrointestinal Tract Tolerance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case Group

Treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation with conventional pharyngeal anesthesia

Case Group

Intervention Type DRUG

Consecutively, all the participants were assigned to case group with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope, same medication which was used for prior pharyngeal anesthesia, or to control group with conventional pharyngeal anesthesia without further treatment. Then we compared the primary outcome measures, such as, frequency of belching and retching of two groups.

Control Group

Treated with conventional pharyngeal anesthesia without further treatment.

No interventions assigned to this group

Interventions

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Case Group

Consecutively, all the participants were assigned to case group with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope, same medication which was used for prior pharyngeal anesthesia, or to control group with conventional pharyngeal anesthesia without further treatment. Then we compared the primary outcome measures, such as, frequency of belching and retching of two groups.

Intervention Type DRUG

Other Intervention Names

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Beracaine Spray

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cheju Halla General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Byung Hyo Cha, MD

President of Digestive Disease Center, Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Byung Hyo Cha, M.D.

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea

Locations

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Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital

Jeju City, Jeju Special Self-Governing Province, South Korea

Site Status

Countries

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South Korea

References

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Gordon MJ, Mayes GR, Meyer GW. Topical lidocaine in preendoscopic medication. Gastroenterology. 1976 Oct;71(4):564-9.

Reference Type BACKGROUND
PMID: 782997 (View on PubMed)

Isenberg G. Topical anesthesia: to use or not to use--that is the question. Gastrointest Endosc. 2001 Jan;53(1):130-3. doi: 10.1067/mge.2001.112093. No abstract available.

Reference Type BACKGROUND
PMID: 11154514 (View on PubMed)

Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.

Reference Type BACKGROUND
PMID: 4835444 (View on PubMed)

Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.

Reference Type BACKGROUND
PMID: 10403727 (View on PubMed)

Lachter J, Jacobs R, Lavy A, Weisler A, Suissa A, Enat R, Eidelman S. Topical pharyngeal anesthesia for easing endoscopy: a double-blind, randomized, placebo-controlled study. Gastrointest Endosc. 1990 Jan-Feb;36(1):19-21. doi: 10.1016/s0016-5107(90)70915-7.

Reference Type BACKGROUND
PMID: 2179038 (View on PubMed)

Leitch DG, Wicks J, el Beshir OA, Ali SA, Chaudhury BK. Topical anesthesia with 50 mg of lidocaine spray facilitates upper gastrointestinal endoscopy. Gastrointest Endosc. 1993 May-Jun;39(3):384-7. doi: 10.1016/s0016-5107(93)70110-8.

Reference Type BACKGROUND
PMID: 8514070 (View on PubMed)

Soma Y, Saito H, Kishibe T, Takahashi T, Tanaka H, Munakata A. Evaluation of topical pharyngeal anesthesia for upper endoscopy including factors associated with patient tolerance. Gastrointest Endosc. 2001 Jan;53(1):14-8. doi: 10.1067/mge.2001.111773.

Reference Type BACKGROUND
PMID: 11154482 (View on PubMed)

Hedenbro JL, Ekelund M, Jansson O, Lindblom A. A randomized, double-blind, placebo-controlled study to evaluate topical anaesthesia of the pharynx in upper gastrointestinal endoscopy. Endoscopy. 1992 Aug;24(6):585-7. doi: 10.1055/s-2007-1010550.

Reference Type BACKGROUND
PMID: 1396370 (View on PubMed)

Karim A, Ahmed S, Siddiqui R, Mattana J. Methemoglobinemia complicating topical lidocaine used during endoscopic procedures. Am J Med. 2001 Aug;111(2):150-3. doi: 10.1016/s0002-9343(01)00763-x. No abstract available.

Reference Type BACKGROUND
PMID: 11498069 (View on PubMed)

Gunaratnam NT, Vazquez-Sequeiros E, Gostout CJ, Alexander GL. Methemoglobinemia related to topical benzocaine use: is it time to reconsider the empiric use of topical anesthesia before sedated EGD? Gastrointest Endosc. 2000 Nov;52(5):692-3. doi: 10.1067/mge.2000.110078. No abstract available.

Reference Type BACKGROUND
PMID: 11060205 (View on PubMed)

Abdallah HY, Shah SA. Methemoglobinemia induced by topical benzocaine: a warning for the endoscopist. Endoscopy. 2002 Sep;34(9):730-4. doi: 10.1055/s-2002-33450.

Reference Type BACKGROUND
PMID: 12195332 (View on PubMed)

Other Identifiers

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2013-M08

Identifier Type: -

Identifier Source: org_study_id

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