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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ASA class I-II
obtaining written informed consent from the parents
aged 20-65 years who were undergoing radical open gastrectomy

Exclusion criteria

abdominal surgery previously
patient who refuse the patient controlled analgesia
unstable angina or congestive heart failure
uncontrolled hypertension (diastolic bp>110mmHg)
coagulopathy
hepatic failure
renal failure
bradycardia on EKG (under 50 bpm)
Ventricular conduction abnormality
drug hyperactivity
neurological or psychiatric illnesses
mental retardation
patients who can't read the consent form due to illiterate or foreigner 14.infection

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine mixed fentanyl based intravenous PCA

Fentanyl 1

Drug

conventional fentanyl-based epidural PCA

Fentanyl 2

Drug

conventional fentanyl based intravenous PCA

Primary outcomes

Postoperative pain

Time frame: 48 hours after operation

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Dec 25, 2014
Registry last updated: Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed