The Effect of Dexmedetomidine on Postoperative Analgesia
Assessment of the Effect of Dexmedetomidine in the Management of Postoperative Pain When Combined With Fentanyl in the Patient-controlled Analgesia
1 other identifier
interventional
95
1 country
1
Brief Summary
The purpose of this study is to determine whether additional Dexmedetomidine to patient controlled analgesia can reduce fentanyl consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMarch 8, 2012
March 1, 2012
8 months
June 13, 2011
March 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
total amount of administered fentanyl
during first 24 hours after surgery
Study Arms (2)
F
PLACEBO COMPARATORFentanyl+Normal saline
D
EXPERIMENTALFentanyl+Dexmedetomidine
Interventions
Eligibility Criteria
You may qualify if:
- Elective surgery for colon cancer
You may not qualify if:
- Liver disease
- Kidney disease
- Allergy for study drugs
- Inability to receive patient controlled analgesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Pharmbio Korea Co., Ltd.collaborator
Study Sites (1)
Seoul national university hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 13, 2011
First Posted
June 14, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 8, 2012
Record last verified: 2012-03