Clinical Trials Logo
  1. Home
  2. Functional Dyspepsia
  3. NCT01053871
  4. Details
NCT01053871 Clinical Trial

Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

Functional Dyspepsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01053871
Other study ID # 2009SDU-QILU-G08
Secondary ID
Status Completed
Phase N/A
First received January 21, 2010
Last updated June 13, 2011
Start date January 2010
Est. completion date May 2010

Study information
Verified date December 2009
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- outpatients attending endomicroscopy

- able to give written informed consent

Exclusion Criteria:

- GI tract malignancy

- coagulopathy

- acute upper digestive tract bleeding

- pregnancy or breast feeding

- allergy to fluorescein sodium

- impaired renal function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• propofol
conscious sedation using propofol
• midazolam with fentanyl
conscious sedation using midazolam with fentanyl

Locations
Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary endomicroscopic image quality 3 months No
Secondary sedation efficacy outcomes,patient assessment,physician assessment 3 months No
See also
  Status Clinical Trial Phase
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04464369 - Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial Phase 4
Completed NCT01671670 - Acupuncture for Patients With Function Dyspepsia Phase 2/Phase 3
Completed NCT00987805 - Efficacy of Banhasasim-tang on Functional Dyspepsia Phase 4
Completed NCT00693407 - Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation N/A
Completed NCT00761358 - To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia Phase 3
Recruiting NCT01240096 - Mirtazapine Versus Placebo in Functional Dyspepsia Phase 4
Recruiting NCT04540549 - Effects of Exercise on Functional Dyspepsia Based on Rome IV N/A
Recruiting NCT03652571 - Nortriptyline for the Treatment of Functional Dyspepsia Phase 3
Recruiting NCT06068114 - Gastric Pathophysiology in Diabetes
Recruiting NCT03825692 - International Clinical Study of Zhizhu Kuanzhong Capsule Phase 4
Not yet recruiting NCT04548011 - Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia N/A
Terminated NCT02567578 - A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia Phase 2
Completed NCT03007433 - Assessment of GI Function to a Large Test Meal by Non-invasive Imaging N/A
Active, not recruiting NCT00990405 - Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia Phase 4
Completed NCT00404534 - Helicobacter Eradication Relief of Dyspeptic Symptoms Phase 3
Completed NCT03043625 - Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia N/A
Completed NCT03225248 - Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia Phase 3
Recruiting NCT05587127 - Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia N/A
Recruiting NCT01021475 - Does Visceral Manipulation Works in Treating Functional Dyspepsia? Phase 1