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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02325882
• Collaborator: (none)
• Enrollment: 171
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Dexmedetomidine; Drug: Fentanyl 1; Drug: Fentanyl 2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional fentanyl-based epidural PCA	Drug: Fentanyl 1; conventional fentanyl-based epidural PCA
Experimental: dexmedetomidine to fentanyl-based intravenous PCA	Drug: Dexmedetomidine; Dexmedetomidine mixed fentanyl based intravenous PCA
Active Comparator: Conventional fentanyl-based intravenous PCA	Drug: Fentanyl 2; conventional fentanyl based intravenous PCA

Outcome Measures

Primary Outcome Measures

1. Postoperative pain [48 hours after operation]

   Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02325882
• Other Study ID Numbers: 4-2014-0883
• First Posted: Dec 25, 2014
• Last Update Posted: Mar 29, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Pain, Postoperative; Fentanyl; Dexmedetomidine

Study Results

No Results Posted as of Mar 29, 2016