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Clinical Trials/NCT02567916
NCT02567916
Completed
Phase 4

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

Kyungpook National University Hospital1 site in 1 country129 target enrollmentApril 2015

Overview

Phase
Phase 4
Intervention
Fresofol
Conditions
Pain
Sponsor
Kyungpook National University Hospital
Enrollment
129
Locations
1
Primary Endpoint
Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol).
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
February 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eun Soo Kim, MD, PhD

Associate Professor

Kyungpook National University Hospital

Eligibility Criteria

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

Arms & Interventions

FRESOFOL MCT

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

Intervention: Fresofol

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).

Intervention: Propofol

Outcomes

Primary Outcomes

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

Time Frame: 2 hours

Secondary Outcomes

  • Patient Satisfaction With Sedation Including the Recall of Pain.(2 hours and 5-7days after the end of the procedure)

Study Sites (1)

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