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Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803449
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief Summary:
Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy

Condition or disease Intervention/treatment Phase
Patient Satisfaction Drug: 50-200mg propofol Drug: 50ug fentanyl Drug: 1 mg midazolam Phase 4

Detailed Description:
This study divide patients into two groups, one will be given propofol midazolam and fentanyl; another group was given propofol with midazolam without fentanyl; to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to group A or B. Participants of group A are given propofol midazolam and fentanyl; while participants of group B are given propofol with midazolam without fentany
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Control group
Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
Drug: 50-200mg propofol
participants in both groups are given standard regimen including 50-200mg propofol.
Other Name: Jingan, J20110055

Drug: 1 mg midazolam
participants in both groups are given standard regimen including 1 mg midazolam.
Other Name: Liyuexi, H10980025

Experimental: Fentanyl group
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
Drug: 50-200mg propofol
participants in both groups are given standard regimen including 50-200mg propofol.
Other Name: Jingan, J20110055

Drug: 50ug fentanyl
participants in fentanyl group are given intervention regimen: 50ug fentanyl.
Other Name: Yichang, H42022076

Drug: 1 mg midazolam
participants in both groups are given standard regimen including 1 mg midazolam.
Other Name: Liyuexi, H10980025




Primary Outcome Measures :
  1. Satisfaction assessed by the rate of vomit and diazzy after the procedure [ Time Frame: half a year ]
    Rates of vomit and diazzy of patients after the procedure between the two groups


Secondary Outcome Measures :
  1. Safety assessed by the rate of hypoxia during the procedure [ Time Frame: half a year ]
    Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds

  2. Safety assessed by the rate of hypotention during the procedure [ Time Frame: half a year ]
    Hypotension, defined as systolic blood pressure <90 mmHg

  3. Safety assessed by the rate of hyoxemia during the procedure [ Time Frame: half a year ]
    Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds

  4. Safety assessed by the rate of breadycardia during the procedure [ Time Frame: half a year ]
    Bradycardia, defined as heart rate <50 beats/min

  5. Safety assessed by the rate of required airway management during the procedure [ Time Frame: half a year ]
    Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia

  6. Safety assessed by the rate of involuntary movement during the procedure [ Time Frame: half a year ]
    Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure



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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 18 or older
  • Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.

Exclusion Criteria:

  • Patients with a history of colorectal surgery
  • Patients with ASA class 4 or 5,
  • Patients with pre-existing hypoxaemia (SpO2<90%),
  • Patients with hypotension (SBP<90mmHg)
  • Patients with bradycardia (HR<50 bpm)
  • patients with severe chronic renal failure (creatinine clearance<30 ml/min)
  • patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
  • patients with pregnancy or lactation
  • Patients hemodynamically unstable
  • Patients unable to give informed consent
  • Patients with a history of drug allergies;

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): NCT03803449


Contacts
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Contact: jing liu +86-18560083755 1057986797@qq.com

Sponsors and Collaborators
Shandong University
Investigators
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Study Chair: yanqing li, Dr. Qilu Hospital of Shandong University
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Responsible Party: Yanqing Li, Principal Investigator, Shandong University
ClinicalTrials.gov Identifier: NCT03803449    
Other Study ID Numbers: 2018SDU-QILU-069
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yanqing Li, Shandong University:
propofol
fentanyl
gastrointestinal endoscopy
Additional relevant MeSH terms:
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Fentanyl
Midazolam
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action