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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03803449
• Other study ID #: 2018SDU-QILU-069
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2019
• Source: Shandong University
• Contact: jing liu
• Phone: +86-18560083755
• Email: 1057986797[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Drug:
• 50-200mg propofol
participants in both groups are given standard regimen including 50-200mg propofol.
• 50ug fentanyl
participants in fentanyl group are given intervention regimen: 50ug fentanyl.
• 1 mg midazolam
participants in both groups are given standard regimen including 1 mg midazolam.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety assessed by the rate of hypoxia during the procedure	Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds	half a year
Secondary	Safety assessed by the rate of hypotention during the procedure	Hypotension, defined as systolic blood pressure <90 mmHg	half a year
Secondary	Safety assessed by the rate of hyoxemia during the procedure	Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds	half a year
Secondary	Safety assessed by the rate of breadycardia during the procedure	Bradycardia, defined as heart rate <50 beats/min	half a year
Secondary	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
Secondary	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