Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP
1 other identifier
interventional
210
1 country
1
Brief Summary
The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJuly 17, 2013
July 1, 2013
8 months
May 29, 2013
July 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Satisfaction scores by endoscopist
30 minutes after the procedure
Secondary Outcomes (2)
Adverse events for sedation
1 day after the procedure
Difficulty scores of maintaining the sedation
30 minutes after the procedure
Study Arms (2)
Intermittent bolus injection of propofol
ACTIVE COMPARATORA loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
Continuous infusion of propofol
ACTIVE COMPARATORPropofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
Interventions
Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
Eligibility Criteria
You may qualify if:
- Patients undergone ERCP for biliary and pancreatic diseases
You may not qualify if:
- Comorbid conditions of ASA class 4-5
- Age under 18 years or over 90 years
- Pregnancy
- Past medication history of benzodiazepine or narcotics
- Known allergy to midazolam or propofol
- hypotension (systolic blood pressure \<90 mmHg), hypoxemia (SaO2 \<90%), or bradycardia (50/min) at baseline measurements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyo-Sang Yoo
Hanyang University Guri Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 29, 2013
First Posted
July 17, 2013
Study Start
September 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
July 17, 2013
Record last verified: 2013-07