A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol
1 other identifier
interventional
129
1 country
1
Brief Summary
The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Apr 2015
Typical duration for phase_4 pain
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
March 23, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 30, 2020
April 1, 2020
10 months
March 23, 2015
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol).
2 hours
Secondary Outcomes (1)
Patient Satisfaction With Sedation Including the Recall of Pain.
2 hours and 5-7days after the end of the procedure
Study Arms (2)
FRESOFOL MCT
EXPERIMENTALTo compare the incidence and intensity of pain on injection that is caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol) .
Propofol
ACTIVE COMPARATORThe purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol).
Interventions
Eligibility Criteria
You may qualify if:
- age \>15 yrs
- ASA (American Society of Anesthesiologists risk class III-IV)I-II
- patients undergoing to gastroscopy
You may not qualify if:
- significant systemic disease (American Society of Anesthesiologists risk class III-IV)
- history of allergic reactions to any of the study drugs
- chronic use of opioid analgesics
- psychiatric disorder
- arrythmia
- pregnancy
- age \<18 yrs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Keimyung University Dongsan Medical Center
Daegu, 700-712, South Korea
Related Publications (1)
Ozawa A, Isono M, Ueno T, Kosaka Y, Nakano T, Inamura M, Kanai A, Okamoto H, Hoka S, Nomiyama S. [Comparison of propofol LCT and propofol MCT/LCT regarding the injection pain at different sites and the memory]. Masui. 2005 Nov;54(11):1241-6. Japanese.
PMID: 16296361BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eun Soo Kim, MD
Keimyung University Dongsan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 23, 2015
First Posted
October 5, 2015
Study Start
April 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2017
Last Updated
April 30, 2020
Record last verified: 2020-04