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The Effect of Dexmedetomidine on Postoperative Analgesia

Primary Purpose

Colon Cancer, Rectal Cancer

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fentanyl
Dexmedetomidine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colon Cancer, Rectal Cancer

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective surgery for colon cancer

Exclusion Criteria:

  • Liver disease
  • Kidney disease
  • Allergy for study drugs
  • Inability to receive patient controlled analgesia

Sites / Locations

  • Seoul national university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

F

D

Arm Description

Fentanyl+Normal saline

Fentanyl+Dexmedetomidine

Outcomes

Primary Outcome Measures

total amount of administered fentanyl

Secondary Outcome Measures

Full Information

First Posted
June 13, 2011
Last Updated
March 6, 2012
Sponsor
Seoul National University Hospital
Collaborators
Pharmbio Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01373021
Brief Title
The Effect of Dexmedetomidine on Postoperative Analgesia
Official Title
Assessment of the Effect of Dexmedetomidine in the Management of Postoperative Pain When Combined With Fentanyl in the Patient-controlled Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Pharmbio Korea Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether additional Dexmedetomidine to patient controlled analgesia can reduce fentanyl consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F
Arm Type
Placebo Comparator
Arm Description
Fentanyl+Normal saline
Arm Title
D
Arm Type
Experimental
Arm Description
Fentanyl+Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl 2500mcg+NS50ml
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml
Primary Outcome Measure Information:
Title
total amount of administered fentanyl
Time Frame
during first 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective surgery for colon cancer Exclusion Criteria: Liver disease Kidney disease Allergy for study drugs Inability to receive patient controlled analgesia
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effect of Dexmedetomidine on Postoperative Analgesia

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