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

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

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

Study Overview

• Status: Unknown
• Conditions: Patient Satisfaction
• Intervention / Treatment: Drug: 50-200mg propofol; Drug: 1 mg midazolam; Drug: 50ug fentanyl

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: jing liu; Phone Number: +86-18560083755; Email: 1057986797@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Chair: yanqing li, Dr., Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: April 22, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: fentanyl; propofol; gastrointestinal endoscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Propofol
• Other Study ID Numbers: 2018SDU-QILU-069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No