Safety and Efficacy of transformable patient positioning device(EZ-FIX) for endoscopic retrograde cholangiopancreatography under intravenous sedation: a prospective, randomized trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001237

Enrollment

Registered

2014-09-25

Start date

2013-06-20

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : ERCP is a kind of high-risk procedure and frequently performed under deep sedation for the accuracy of the procedure and safety of patient. EZ-FIX is a patient positioning device with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient older than 18 years need the therapeutic ERCP over 15 minites.

Exclusion criteria

Exclusion criteria: outpatients, pregnancy, allergy to midazolam or profopol, peaple experienced complication during sedative endoscopy, alcohol abuser ,history of neuromuscular disease, acute or chronic pumonary disesase, sleep apnea, American Society of Anesthesiologists (ASA) class V, mental retardation, not agreed with informed consent.

Design outcomes

Primary

Measure	Time frame
dose of propofol;incidence of hypoxia, hypotension	—

Secondary

Measure	Time frame
recovery time ;satisfaction degree of doctor and nurse	—

Countries

Korea, Republic of

Contacts

Public ContactJoung-Ho Han

Chungbuk National University Hospital

Outcome results