Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Care Provider)
- Study Primary Completion Date: December 2015
Interventions
- Drug: Nefopam
- Drug: Ketamine
- Drug: Saline
Arms, Groups and Cohorts
- Active Comparator: Nefopam
- The generic name is ‘ACUPAN’. It is infused during operation. A induction dose is 0.3mg/Kg. A maintenance dose is 65 mcg/kg/hr
- Active Comparator: Ketamine
- It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr
- Placebo Comparator: Saline
- It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr
Clinical Trial Outcome Measures
Primary Measures
- analgesic requirement
- Time Frame: During 1 hour at PACU
- duration of analgesic free
- Time Frame: During 1 hour at PACU
Secondary Measures
- analgesic requirement
- Time Frame: During 8 hours after arriving at ward
- Pain on the VAS scale
- Time Frame: During 1 hour at PACU
Participating in This Clinical Trial
Inclusion Criteria
- patient who scheduled laparoscopic cholecystectomy under general anesthesia – American Society of Anesthesiologist(ASA) class I or II – adult patient (age 20 – 65) Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 65 Years
Investigator Details
- Lead Sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Lee Mi Hyeon, assistant professor – Hallym University Kangnam Sacred Heart Hospital
- Overall Contact(s)
- Mi hyun Lee, +82-02-829-5230, md1212@naver.com
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