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

Kyungpook National University

Status and phase: Completed; Phase 4

Conditions: Complication of Injection; Pain

Treatments: Drug: Fresofol; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02567916

2014-08-026-001

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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129 participants in 2 patient groups

FRESOFOL MCT

Experimental group

Description:

To compare the incidence and intensity of pain on injection that is caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol) .

Treatment:

Drug: Fresofol

Propofol

Active Comparator group

Description:

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).

Treatment:

Drug: Propofol