Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study
Overview
- Phase
- Phase 4
- Intervention
- 50-200mg propofol
- Conditions
- Patient Satisfaction
- Sponsor
- Shandong University
- Enrollment
- 500
- Primary Endpoint
- Satisfaction assessed by the rate of vomit and diazzy after the procedure
- Last Updated
- 7 years ago
Overview
Brief Summary
Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy
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.
Investigators
Yanqing Li
Principal Investigator
Shandong University
Eligibility 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
Arms & Interventions
Control group
Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
Intervention: 50-200mg propofol
Control group
Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
Intervention: 1 mg midazolam
Fentanyl group
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
Intervention: 50-200mg propofol
Fentanyl group
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
Intervention: 50ug fentanyl
Fentanyl group
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
Intervention: 1 mg midazolam
Outcomes
Primary Outcomes
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 Outcomes
- Safety assessed by the rate of hypoxia during the procedure(half a year)
- Safety assessed by the rate of hypotention during the procedure(half a year)
- Safety assessed by the rate of hyoxemia during the procedure(half a year)
- Safety assessed by the rate of breadycardia during the procedure(half a year)
- Safety assessed by the rate of required airway management during the procedure(half a year)
- Safety assessed by the rate of involuntary movement during the procedure(half a year)