Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 2014

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.

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Case Group
    • Treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation with conventional pharyngeal anesthesia
  • Control Group
    • Treated with conventional pharyngeal anesthesia without further treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of Belching and retching
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cheju Halla General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Byung Hyo Cha, MD, President of Digestive Disease Center, Internal Medicine – Cheju Halla General Hospital
  • Overall Official(s)
    • Byung Hyo Cha, M.D., Principal Investigator, Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea

References

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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