NCT02307773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
Last Updated

January 13, 2015

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

December 1, 2014

Last Update Submit

January 12, 2015

Conditions

C.Medical Procedure; Digestive SystemDisorder of Upper Gastrointestinal TractTolerance

Keywords

Upper Gastrointestinal EndoscopyPharyngeal AnesthesiaLidocaineBelchingRetchingTolerance

Outcome Measures

Primary Outcomes (1)

  • Frequency of Belching and retching

    Belching was defined as release of gas from the digestive tract (mainly esophagus and stomach) through the mouth and retching was defined as reverse peristaltic movement of the stomach and esophagus without vomiting.

    Participants will be followed for the duration of hospital stay, expected average of 1-2 hours

Secondary Outcomes (1)

  • Adverse events

    Participants will be followed for the duration of hospital stay, expected average of 1-2 hours

Study Arms (2)

Case Group

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

Drug: Case Group

Control Group

Treated with conventional pharyngeal anesthesia without further treatment.

Interventions

Case GroupDRUG

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.

Also known as: Beracaine Spray
Case Group

Eligibility Criteria

Age16 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jeju City, Jeju Special Self-Governing Province, 690-766, South Korea

Location

Related Publications (11)

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

    PMID: 782997BACKGROUND

  • 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.

    PMID: 11154514BACKGROUND

  • 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.

    PMID: 4835444BACKGROUND

  • 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.

    PMID: 10403727BACKGROUND

  • 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.

    PMID: 2179038BACKGROUND

  • 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.

    PMID: 8514070BACKGROUND

  • 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.

    PMID: 11154482BACKGROUND

  • 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.

    PMID: 1396370BACKGROUND

  • 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.

    PMID: 11498069BACKGROUND

  • 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.

    PMID: 11060205BACKGROUND

  • 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.

    PMID: 12195332BACKGROUND

MeSH Terms

Conditions

Eructation

Interventions

Diagnosis-Related Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prospective Payment SystemReimbursement MechanismsInsurance, Health, ReimbursementFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Officials

  • Byung Hyo Cha, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Digestive Disease Center, Internal Medicine

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 4, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 13, 2015

Record last verified: 2014-12

Locations

KR(1)