A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol

Phase 4

Completed

• Conditions: Pain; Complication of Injection
• Interventions: Drug: Fresofol; Drug: Propofol

• Registration Number: NCT02567916
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-23
• Study Start: 2015-04
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-05
• Primary Completion: 2016-02
• Study Completion: 2017-02
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• age >15 yrs
• ASA (American Society of Anesthesiologists risk class III-IV)I-II
• patients undergoing to gastroscopy

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FRESOFOL MCT	Fresofol	To compare the incidence and intensity of pain on injection that is caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol) .
Propofol	Propofol	The 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).

Primary Outcome Measures

Name	Time	Method
Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol).	2 hours

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction With Sedation Including the Recall of Pain.	2 hours and 5-7days after the end of the procedure

Trial Locations

Locations (1)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of