The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy

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

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conventional fentanyl-based epidural PCA

Group Type ACTIVE_COMPARATOR

Fentanyl 1

Intervention Type DRUG

conventional fentanyl-based epidural PCA

dexmedetomidine to fentanyl-based intravenous PCA

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine mixed fentanyl based intravenous PCA

Conventional fentanyl-based intravenous PCA

Group Type ACTIVE_COMPARATOR

Fentanyl 2

Intervention Type DRUG

conventional fentanyl based intravenous PCA

Interventions

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Dexmedetomidine

Dexmedetomidine mixed fentanyl based intravenous PCA

Intervention Type DRUG

Fentanyl 1

conventional fentanyl-based epidural PCA

Intervention Type DRUG

Fentanyl 2

conventional fentanyl based intravenous PCA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged 20-65 years who were undergoing radical open gastrectomy

Exclusion Criteria

1. abdominal surgery previously
2. patient who refuse the patient controlled analgesia
3. unstable angina or congestive heart failure
4. uncontrolled hypertension (diastolic bp\>110mmHg)
5. coagulopathy
6. hepatic failure
7. renal failure
8. bradycardia on EKG (under 50 bpm)
9. Ventricular conduction abnormality
10. drug hyperactivity
11. neurological or psychiatric illnesses
12. mental retardation
13. patients who can't read the consent form due to illiterate or foreigner 14.infection

15\. pregnant 16. obesity (BMI \> 30kg/m2)

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes