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NCT Number: NCT02307773

Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy

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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Key information

Conditions

C.Medical Procedure; Digestive System Disorder of Upper Gastrointestinal Tract Eructation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Tolerance

Age range

16 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case Group

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.

Other names: Beracaine Spray

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cheju Halla General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2014
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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