The Effect of Dexmedetomidine on Postoperative Analgesia | NCT01373021

Studies
The Effect of Dexmedetomidine on Postoperative Analgesia

NCT01373021

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 8, 2012Estimated

Enrollment

95Actual

Phase

Phase 4

Conditions

Colon Cancer, Rectal Cancer

Interventions

Fentanyl
Dexmedetomidine

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

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

Jun 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jun 13, 2011

First Submission Date that Met QC Criteria

Jun 13, 2011

First Posted Date

Jun 14, 2011Estimated

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 6, 2012

Last Update Posted Date

Mar 8, 2012Estimated

Name	Class
Pharmbio Korea Co., Ltd.	INDUSTRY

Description Module

Brief Summary

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

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
F	Placebo Comparator	Fentanyl+Normal saline	Drug: Fentanyl
D	Experimental	Fentanyl+Dexmedetomidine	Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug	Fentanyl 2500mcg+NS50ml	F
Dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total amount of administered fentanyl		during first 24 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 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
Seoul national university hospital		Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided