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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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Fentanyl 1
Fentanyl 2
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Conventional fentanyl-based epidural PCA

dexmedetomidine to fentanyl-based intravenous PCA

Conventional fentanyl-based intravenous PCA

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 21, 2014
Last Updated
March 27, 2016
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02325882
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional fentanyl-based epidural PCA
Arm Type
Active Comparator
Arm Title
dexmedetomidine to fentanyl-based intravenous PCA
Arm Type
Experimental
Arm Title
Conventional fentanyl-based intravenous PCA
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine mixed fentanyl based intravenous PCA
Intervention Type
Drug
Intervention Name(s)
Fentanyl 1
Intervention Description
conventional fentanyl-based epidural PCA
Intervention Type
Drug
Intervention Name(s)
Fentanyl 2
Intervention Description
conventional fentanyl based intravenous PCA
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs
Time Frame
48 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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