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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Fentanyl 1; Drug: Fentanyl 2; Drug: Dexmedetomidine

• Registration Number: NCT02325882
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-21
• Study First Submitted QC: 2014-12-21
• Study First Posted: 2014-12-25
• Study Start: 2015-03
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-27
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional fentanyl-based epidural PCA	Fentanyl 1	-
Conventional fentanyl-based intravenous PCA	Fentanyl 2	-
dexmedetomidine to fentanyl-based intravenous PCA	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain	48 hours after operation	Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of