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

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325882
• Other study ID #: 4-2014-0883
• Status: Completed
• Phase: N/A
• First received: December 21, 2014
• Last updated: March 27, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine mixed fentanyl based intravenous PCA
• Fentanyl 1
conventional fentanyl-based epidural PCA
• Fentanyl 2
conventional fentanyl based intravenous PCA

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs	48 hours after operation	No