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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02325882

Enrollment

171

Registered

2014-12-25

Start date

2015-03-31

Completion date

2016-03-31

Last updated

2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGDexmedetomidine

Dexmedetomidine mixed fentanyl based intravenous PCA

DRUGFentanyl 1

conventional fentanyl-based epidural PCA

DRUGFentanyl 2

conventional fentanyl based intravenous PCA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	48 hours after operation	Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026