Patient Satisfaction
Conditions
Keywords
propofol, fentanyl, gastrointestinal endoscopy
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.
Interventions
DRUG50-200mg propofol
participants in both groups are given standard regimen including 50-200mg propofol.
DRUG50ug fentanyl
participants in fentanyl group are given intervention regimen: 50ug fentanyl.
DRUG1 mg midazolam
participants in both groups are given standard regimen including 1 mg midazolam.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 hypoxia during the procedure | half a year | Hypoxia, defined as peripheral oxygen saturation \<90% for \>30 seconds |
| 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 |
| Safety assessed by the rate of breadycardia during the procedure | half a year | Bradycardia, defined as heart rate \<50 beats/min |
Contacts
Primary Contactjing liu
Outcome results
None listed