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
  Purpose

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


Condition Intervention Phase
Colon Cancer, Rectal Cancer
Drug: Fentanyl
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • total amount of administered fentanyl [ Time Frame: during first 24 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: F
Fentanyl+Normal saline
Drug: Fentanyl
Fentanyl 2500mcg+NS50ml
Experimental: D
Fentanyl+Dexmedetomidine
Drug: Dexmedetomidine
Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective surgery for colon cancer

Exclusion Criteria:

  • Liver disease
  • Kidney disease
  • Allergy for study drugs
  • Inability to receive patient controlled analgesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373021

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

No publications provided

Responsible Party: Yong Chul Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01373021     History of Changes
Other Study ID Numbers: sunrud1129
Study First Received: June 13, 2011
Last Updated: March 6, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Dexmedetomidine
Fentanyl
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014