Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy

NCT02307773 — Completed, 497 participants, Cheju Halla General Hospital

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Does Use of Lidocaine Spray on an Endoscope Immediately Before Insertion Improve Patient Tolerance to Endoscopy? A Single Center, Case-Control Study.

RegistryNCT02307773
StatusCompleted
Study typeObservational
Enrollment497 (Actual)
SponsorCheju Halla General Hospital (Other)
ConditionsC.Medical Procedure; Digestive System, Disorder of Upper Gastrointestinal Tract, Tolerance
InterventionsCase Group (Drug)
Datesstart 2013-11-01, primary completion 2014-05-01, completion 2014-05-01, first posted 2014-12-04, last updated 2015-01-13
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for C.Medical Procedure; Digestive System All trials for Disorder of Upper Gastrointestinal Tract All trials of Case Group

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Case GroupDrug: Case GroupTreated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation with conventional pharyngeal anesthesia
Control GroupTreated with conventional pharyngeal anesthesia without further treatment.
  • Case Group (Drug), also known as Beracaine Spray: 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.

+Outcome measures

Primary outcomes

  • Frequency of Belching and retching [Participants will be followed for the duration of hospital stay, expected average of 1-2 hours]: 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.

Secondary outcomes

  • Adverse events [Participants will be followed for the duration of hospital stay, expected average of 1-2 hours]: Events suspected as Aspiration pneumonia, methemoglobinemia

+Eligibility

Sex: All, ages: 16 Years to 89 Years

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

+Locations (1)

FacilityCityCountryStatus
Digestive Disease Center and Department of Internal Medicine, Cheju Halla General HospitalJeju City, Jeju Special Self-Governing ProvinceSouth Korea

+Publications

  • Gordon MJ, Mayes GR, Meyer GW. Topical lidocaine in preendoscopic medication. Gastroenterology. 1976 Oct;71(4):564-9. PMID 782997
  • 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 11154514
  • 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 4835444
  • 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 10403727
  • 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 2179038
  • 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 8514070
  • 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 11154482
  • 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 1396370
  • 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 11498069
  • 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 11060205
  • 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 12195332

+Investigators

  • Byung Hyo Cha, M.D., Principal investigator, Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea