Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174588
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.

Condition or disease Intervention/treatment Phase
EGD Procedure Drug: Midazolam + propofol Drug: propofol Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : January 7, 2013
Actual Primary Completion Date : February 4, 2015
Actual Study Completion Date : February 4, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: balanced propofol group Drug: Midazolam + propofol
Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.

Active Comparator: propofol alone group Drug: propofol
propofol are used for sedation drug




Primary Outcome Measures :
  1. visual analog scale [ Time Frame: Within the 24 hours after EGD ]
    The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone


Secondary Outcome Measures :
  1. complications rates [ Time Frame: Within the 1 hour after EGD ]
    The recovery time after EGD following balanced propofol sedation versus propofol sedation alone. The safety after EGD following balanced propofol sedation versus propofol sedation alone


Other Outcome Measures:
  1. complications rates [ Time Frame: Within the 1 hour after EGD ]
    The safety after EGD following balanced propofol sedation versus propofol sedation alone

  2. total dose of the sedation drugs [ Time Frame: Within the 1 hour after EGD ]
    The economy after EGD following balanced propofol sedation versus propofol sedation alone

  3. visual analog scale [ Time Frame: Within the 1 hour after EGD ]
    The endoscopist's satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. over 19 years old, male and female
  2. patients who have plan to get esophagogastroduodenoscopy (EGD)

Exclusion Criteria:

  1. ASA class III or IV
  2. Allergies to propofol, sulfites or eggs
  3. patients who had surgery for esophagus, stomach or duodenum
  4. inpatients
  5. patients who had sleep apnea, gastroparesis or achalasia
  6. patients who are taking sedative drugs more than 6 months
  7. pregnancy
  8. hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%)
  9. psychiatric or neurologic problems (ex. epilepsy or dementia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174588


Locations
Layout table for location information
Korea, Republic of
Yonsei university College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02174588    
Other Study ID Numbers: 4-2012-0801
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Keywords provided by Yonsei University:
sedation, propofol, midazolam
Additional relevant MeSH terms:
Layout table for MeSH terms
Midazolam
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action