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
1 other identifier
interventional
171
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2014
CompletedFirst Posted
Study publicly available on registry
December 25, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 29, 2016
March 1, 2016
1 year
December 21, 2014
March 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs
48 hours after operation
Study Arms (3)
Conventional fentanyl-based epidural PCA
ACTIVE COMPARATORdexmedetomidine to fentanyl-based intravenous PCA
EXPERIMENTALConventional fentanyl-based intravenous PCA
ACTIVE COMPARATORInterventions
Dexmedetomidine mixed fentanyl based intravenous PCA
conventional fentanyl based intravenous PCA
Eligibility Criteria
You may qualify if:
- ASA class I-II
- obtaining written informed consent from the parents
- aged 20-65 years who were undergoing radical open gastrectomy
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2014
First Posted
December 25, 2014
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 29, 2016
Record last verified: 2016-03