The Postoperative Analgesic Effect of Combination With De... | NCT02325882

Studies
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

NCT02325882

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Mar 29, 2016Estimated

Enrollment

171Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Dexmedetomidine
Fentanyl 1
Fentanyl 2

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Dec 21, 2014

First Submission Date that Met QC Criteria

Dec 21, 2014

First Posted Date

Dec 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2016

Last Update Posted Date

Mar 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

171Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Conventional fentanyl-based epidural PCA	Active Comparator	Drug: Fentanyl 1
dexmedetomidine to fentanyl-based intravenous PCA	Experimental	Drug: Dexmedetomidine
Conventional fentanyl-based intravenous PCA	Active Comparator	Drug: Fentanyl 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Dexmedetomidine mixed fentanyl based intravenous PCA	dexmedetomidine to fentanyl-based intravenous PCA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine		Seoul	Seoul	120-752	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D020927	Dexmedetomidine
C030592	3-methylfentanyl