Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time

Last updated: December 2, 2015
Sponsor: Brooke Army Medical Center
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Colic

Dysmenorrhea (Painful Periods)

Heartburn

Treatment

N/A

Clinical Study ID

NCT02620501
BrookeAMC
  • Ages 18-89
  • All Genders

Study Summary

Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • EGD alone performed by staff gastroenterologist as an outpatient

  • Between the age of 18 and 89

  • Not requiring anesthesia support or use of medications other than fentanyl andmidazolam

Exclusion

Exclusion Criteria:

  • Prior history of head and neck surgery

  • Known hypersensitivity to local anesthetics, the amide type or any components of thetopical lidocaine

  • Patients having interventions other than polypectomy performed

  • Pregnant or breast feeding females

  • Patients with severe liver impairment

  • Known hypersensitivity to benzodiazepine or fentanyl

Study Design

Total Participants: 106
Study Start date:
July 01, 2015
Estimated Completion Date:
May 31, 2016

Study Description

The study will be a double blinded randomized placebo controlled trial

Patients between 18 and 89 years old who are scheduled for EGD may be eligible to enroll in the study. Potential subjects will be sought through referral by their treating attending and fellow gastroenterologist, who will be apprised of the inclusion and exclusion criteria. Patients possibly meeting inclusive and exclusive criteria will be approached and discussed the study further with the investigators. Those expressing a desire to participate in the study will be given written informed consent prior to participation. The investigators will enroll patients into the study with a goal of at least 53 patients in each group which is the number of patients our statistician recommended to appropriately power our study.

Patients who consent to enroll in the study will be randomized into 2 groups. Group 1: Swish and swallow 10ml of 2% lidocaine solution Group 2: Swish and swallow 10ml of 0.45% sodium chloride solution

The patients will then undergo endoscopy for the indication identified in their clinic appointment. Following the procedure, patients will be taken to the recovery area and recovered per clinic protocol. The endoscopist will complete a satisfaction questionnaire. The day following the procedure a nurse will call to check for post-operative complications per clinic protocol. The day following, an investigator will also call to perform a patient satisfaction survey..

Connect with a study center

  • Brooke Army Medical Center

    Ft. Sam Houston, Texas 78219
    United States

    Active - Recruiting

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