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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