The Application of Spasmolytic in PCLE Examination of Superior Gastrointestinal Endoscope

Shandong University

Status and phase: Completed; Phase 1

Conditions: Using Copolamine Butylbromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination

Treatments: Drug: normal saline; Drug: Scopolamine Hydrobromide

Study type: Interventional

Funder types: Other

Identifiers

NCT02811341

2015SDU-QILU-G01

Details and patient eligibility

About

Scopolamine butylbromide might be helpful for the outcome of superior gastrointestinal endoscope examination.

Full description

The peristalsis of gastrointestinal tract has a adverse affection on the process of the PCLE examination .Scopolamine butylbromide is a widely used spasmolytic，which can reduce the peristalsis of gastrointestinal tract effectly.The application of it may benefit the images'quality ,the acurrate of diagnosis and shorten the examination time.

Enrollment: 122 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• outpatients attending endomicroscopy
• able to give written informed consent

Exclusion criteria

• coagulopathy
• acute upper digestive tract bleeding
• pregnancy or breast feeding
• allergy to fluorescein sodium
• impaired renal function

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups, including a placebo group

A group

Placebo Comparator group

Description:

Using normal saline before pcle examination

Treatment:

Drug: normal saline

B group

Experimental group

Description:

Using Scopolamine Hydrobromide before pcle examination

Treatment:

Drug: Scopolamine Hydrobromide