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

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

Detailed Description
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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.

Official Title
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Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study

Conditions
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Patient Satisfaction

Intervention / Treatment
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* Drug: 50-200mg propofol
* Drug: 50ug fentanyl
* Drug: 1 mg midazolam


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam | Drug: 50-200mg propofol<br>* participants in both groups are given standard regimen including 50-200mg propofol.<br>* Other names: Jingan, J20110055;Drug: 1 mg midazolam<br>* participants in both groups are given standard regimen including 1 mg midazolam.<br>* Other names: Liyuexi, H10980025;|
| Experimental: Fentanyl group<br>Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam. | Drug: 50-200mg propofol<br>* participants in both groups are given standard regimen including 50-200mg propofol.<br>* Other names: Jingan, J20110055;Drug: 50ug fentanyl<br>* participants in fentanyl group are given intervention regimen: 50ug fentanyl.<br>* Other names: Yichang, H42022076;Drug: 1 mg midazolam<br>* participants in both groups are given standard regimen including 1 mg midazolam.<br>* Other names: Liyuexi, H10980025;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction assessed by the rate of vomit and diazzy after the procedure | Rates of vomit and diazzy of patients after the procedure between the two groups | half a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the rate of hypoxia during the procedure | Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds | half a year | 
| Safety assessed by the rate of hypotention during the procedure | Hypotension, defined as systolic blood pressure <90 mmHg | half a year | 
| Safety assessed by the rate of hyoxemia during the procedure | Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds | half a year | 
| Safety assessed by the rate of breadycardia during the procedure | Bradycardia, defined as heart rate <50 beats/min | half a year | 
| Safety assessed by the rate of required airway management during the procedure | Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia | half a year | 
| Safety assessed by the rate of involuntary movement during the procedure | Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure | half a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, fentanyl, gastrointestinal endoscopy