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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Complication of Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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FRESOFOL MCT

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

Group Type EXPERIMENTAL

Fresofol

Intervention Type DRUG

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).

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Interventions

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Fresofol

Intervention Type DRUG

Propofol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No