The Effect of Dexmedetomidine on Postoperative Analgesia

This study has been completed.

Sponsor:

Collaborator:

Pharmbio Korea Co., Ltd.

Information provided by (Responsible Party):

Yong Chul Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01373021

First received: June 13, 2011

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 13, 2011
Last Updated Date	March 6, 2012
Start Date ^ICMJE	June 2011
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 13, 2011)	total amount of administered fentanyl [ Time Frame: during first 24 hours after surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01373021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Dexmedetomidine on Postoperative Analgesia
Official Title ^ICMJE	Assessment of the Effect of Dexmedetomidine in the Management of Postoperative Pain When Combined With Fentanyl in the Patient-controlled Analgesia
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Health Services Research
Condition ^ICMJE	Colon Cancer, Rectal Cancer
Intervention ^ICMJE	Drug: Fentanyl Fentanyl 2500mcg+NS50ml Drug: Dexmedetomidine Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml
Study Arm (s)	Placebo Comparator: F Fentanyl+Normal saline Intervention: Drug: Fentanyl Experimental: D Fentanyl+Dexmedetomidine Intervention: Drug: Dexmedetomidine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	95
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Elective surgery for colon cancer Exclusion Criteria: Liver disease Kidney disease Allergy for study drugs Inability to receive patient controlled analgesia
Gender	Both
Ages	20 Years to 74 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01373021
Other Study ID Numbers ^ICMJE	sunrud1129
Has Data Monitoring Committee	Not Provided
Responsible Party	Yong Chul Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Pharmbio Korea Co., Ltd.
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top