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

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Patient Satisfaction

Treatments: Drug: 1 mg midazolam; Drug: 50ug fentanyl; Drug: 50-200mg propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03803449

2018SDU-QILU-069

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Control group

Active Comparator group

Description:

Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam

Treatment:

Drug: 50-200mg propofol

Drug: 1 mg midazolam

Fentanyl group

Experimental group

Description:

Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.

Treatment:

Drug: 50-200mg propofol

Drug: 50ug fentanyl

Drug: 1 mg midazolam