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

Yonsei University

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Fentanyl 2; Drug: Dexmedetomidine; Drug: Fentanyl 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02325882

4-2014-0883

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 3 patient groups

Conventional fentanyl-based epidural PCA

Active Comparator group

Treatment:

Drug: Fentanyl 1

dexmedetomidine to fentanyl-based intravenous PCA

Experimental group

Treatment:

Drug: Dexmedetomidine

Conventional fentanyl-based intravenous PCA

Active Comparator group

Treatment:

Drug: Fentanyl 2