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

NCT03803449 | Unknown Phase 4 DMC

• 1 other identifier: 2018SDU-QILU-069
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Patient Satisfaction

Keywords

propofol; fentanyl; gastrointestinal endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Safety assessed by the rate of hypoxia during the procedure

  half a year

• Safety assessed by the rate of hypotention during the procedure

  half a year

• Safety assessed by the rate of hyoxemia during the procedure

  half a year

• Safety assessed by the rate of breadycardia during the procedure

  half a year

• Safety assessed by the rate of required airway management during the procedure

  half a year

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Drug: 50-200mg propofol; Drug: 1 mg midazolam

Fentanyl group

EXPERIMENTAL

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

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

Interventions

50-200mg propofol DRUG

participants in both groups are given standard regimen including 50-200mg propofol.

Also known as: Jingan, J20110055

Control group; Fentanyl group

50ug fentanyl DRUG

participants in fentanyl group are given intervention regimen: 50ug fentanyl.

Also known as: Yichang, H42022076

Fentanyl group

1 mg midazolam DRUG

participants in both groups are given standard regimen including 1 mg midazolam.

Also known as: Liyuexi, H10980025

Control group; Fentanyl group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or older
• Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong University: lead

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Propofol; Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• yanqing li, Dr.

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

jing liu

CONTACT

+86-18560083755; 1057986797@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: January 14, 2019
• Study Start: January 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: October 30, 2019
• Last Updated: January 14, 2019

Record last verified: 2019-01