Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia
1 other identifier
interventional
60
1 country
1
Brief Summary
Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for postoperative pain control, and reduce the needs of opioid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 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
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedSeptember 2, 2015
August 1, 2015
9 months
July 2, 2015
August 31, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
analgesic requirement
During 1 hour at PACU
duration of analgesic free
During 1 hour at PACU
Secondary Outcomes (2)
analgesic requirement
During 8 hours after arriving at ward
Pain on the VAS scale
During 1 hour at PACU
Study Arms (3)
Nefopam
ACTIVE COMPARATORThe generic name is 'ACUPAN'. It is infused during operation. A induction dose is 0.3mg/Kg. A maintenance dose is 65 mcg/kg/hr
Ketamine
ACTIVE COMPARATORIt is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr
Saline
PLACEBO COMPARATORIt is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr
Interventions
Eligibility Criteria
You may qualify if:
- patient who scheduled laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologist(ASA) class I or II
- adult patient (age 20 - 65)
You may not qualify if:
- patient who has liver disease
- patient who has kidney disease
- patient who has diabetes mellitus(DM) or heart disease
- patient who takes opioid or beta-blocker
- patient who has airway disease
- patient who has allergy with the drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hallym University Kangnam Sacred Heart Hospita
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
July 2, 2015
First Posted
July 9, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Last Updated
September 2, 2015
Record last verified: 2015-08