The Effect of Dexmedetomidine on Postoperative Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373021
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : March 8, 2012
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
Yong Chul Kim, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Colon Cancer, Rectal Cancer Drug: Fentanyl Drug: Dexmedetomidine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Assessment of the Effect of Dexmedetomidine in the Management of Postoperative Pain When Combined With Fentanyl in the Patient-controlled Analgesia
Study Start Date : June 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: F
Fentanyl+Normal saline
Drug: Fentanyl
Fentanyl 2500mcg+NS50ml

Experimental: D
Drug: Dexmedetomidine
Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml

Primary Outcome Measures :
  1. total amount of administered fentanyl [ Time Frame: during first 24 hours after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective surgery for colon cancer

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01373021

Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Pharmbio Korea Co., Ltd.

Responsible Party: Yong Chul Kim, Professor, Seoul National University Hospital Identifier: NCT01373021     History of Changes
Other Study ID Numbers: sunrud1129
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Adjuvants, Anesthesia
Anesthetics, Intravenous