Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy

Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307773
• Other study ID #: 2013-M08
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: January 12, 2015
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: Cheju Halla General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 89 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital	Jeju-si	Jeju Special Self-Governing Province

Sponsors (1)

Lead Sponsor	Collaborator
Cheju Halla General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

Abdallah HY, Shah SA. Methemoglobinemia induced by topical benzocaine: a warning for the endoscopist. Endoscopy. 2002 Sep;34(9):730-4. — View Citation

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

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. — View Citation

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. — View Citation

Isenberg G. Topical anesthesia: to use or not to use--that is the question. Gastrointest Endosc. 2001 Jan;53(1):130-3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events	Events suspected as Aspiration pneumonia, methemoglobinemia	Participants will be followed for the duration of hospital stay, expected average of 1-2 hours	No