跳至主要内容
临床试验/NCT02620501
NCT02620501Unknown不适用

Does Topical Lidocaine Reduce The Amount of Intravenous Conscious Sedation Required To Complete Diagnostic Upper Endoscopy and Shorten Recovery Time? A Double Blinded, Randomized, Placebo Controlled Study.

Brooke Army Medical Center1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
106
试验地点
1
主要终点
Amount of sedation used

研究概览

简要总结

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.

详细描述

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..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 and midazolam

排除标准

  • Prior history of head and neck surgery
  • Known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine
  • Patients having interventions other than polypectomy performed
  • Pregnant or breast feeding females
  • Patients with severe liver impairment
  • Known hypersensitivity to benzodiazepine or fentanyl

研究组 & 干预措施

Placebo

Placebo Comparator

Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD

干预措施: Placebo (Drug)

Experimental

Experimental

Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD

干预措施: Lidocaine (Drug)

结局指标

主要结局

Amount of sedation used

时间窗: 60 minutes

We will record the amount of sedation used during the procedure

次要结局

  • Recovery time(120 minutes)
  • Patient and physician satisfaction(24 hours)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Adam Tritsch

Gastroenterology Fellow

Brooke Army Medical Center

研究点 (1)

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