The Effect of Dexmedetomidine on Postoperative Analgesia
This study has been completed.
Sponsor:
Seoul National University Hospital
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
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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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Fentanyl
Fentanyl citrate
Dexmedetomidine
Dexmedetomidine hydrochloride
U.S. FDA Resources
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 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:
|
Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fentanyl Dexmedetomidine |
Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on June 18, 2013