Clinical trial NCT03803449: Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy
Official title: Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patient Satisfaction
Keywords: propofol
fentanyl
gastrointestinal endoscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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
* Patients with a history of drug allergies;

Primary outcomes:
measure: Satisfaction assessed by the rate of vomit and diazzy after the procedure
timeFrame: half a year
Secondary outcomes:
measure: Safety assessed by the rate of hypoxia during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of hypotention during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of hyoxemia during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of breadycardia during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of required airway management during the procedure
timeFrame: half a year
measure: Safety assessed by the rate of involuntary movement during the procedure
timeFrame: half a year
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: yanqing li, Dr.
role: STUDY_CHAIR
References: