Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy
- Conditions
- Patient Satisfaction
- Interventions
- Registration Number
- NCT03803449
- Lead Sponsor
- Shandong University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- Patients aged 18 or older
- Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fentanyl group 50ug fentanyl Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam. Fentanyl group 1 mg midazolam Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam. Control group 50-200mg propofol Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam Fentanyl group 50-200mg propofol Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam. Control group 1 mg midazolam Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
- Primary Outcome Measures
Name Time Method Satisfaction assessed by the rate of vomit and diazzy after the procedure half a year Rates of vomit and diazzy of patients after the procedure between the two groups
- Secondary Outcome Measures
Name Time Method Safety assessed by the rate of hypoxia during the procedure half a year Hypoxia, defined as peripheral oxygen saturation \<90% for \>30 seconds
Safety assessed by the rate of hypotention during the procedure half a year Hypotension, defined as systolic blood pressure \<90 mmHg
Safety assessed by the rate of hyoxemia during the procedure half a year Hypoxia, defined as peripheral oxygen saturation \<90% for \>30 seconds
Safety assessed by the rate of breadycardia during the procedure half a year Bradycardia, defined as heart rate \<50 beats/min
Safety assessed by the rate of required airway management during the procedure half a year Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia
Safety assessed by the rate of involuntary movement during the procedure half a year Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure