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

• ClinicalTrials.gov Identifier: NCT03803449
• Recruitment Status: Unknown
• First Posted: January 14, 2019
• Last Update Posted: January 14, 2019
• Sponsor: Shandong University
• Information provided by (Responsible Party): Yanqing Li, Shandong University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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;

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Shandong University

Investigators

• Study Chair: yanqing li, Dr.; Qilu Hospital of Shandong University

More Information

• Responsible Party: Yanqing Li, Principal Investigator, Shandong University
• ClinicalTrials.gov Identifier: NCT03803449
• Other Study ID Numbers: 2018SDU-QILU-069
• First Posted: January 14, 2019
• Last Update Posted: January 14, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

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