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Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

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ClinicalTrials.gov Identifier: NCT02493231
Recruitment Status : Unknown
Verified August 2015 by Lee Mi Hyeon, Hallym University Kangnam Sacred Heart Hospital.
Recruitment status was:  Recruiting
First Posted : July 9, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Lee Mi Hyeon, Hallym University Kangnam Sacred Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Cholecystitis Drug: Nefopam Drug: Ketamine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Study Start Date : March 2015
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Nefopam
Active Comparator: Ketamine
It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr
Drug: Ketamine
Placebo Comparator: Saline
It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr
Drug: Saline



Primary Outcome Measures :
  1. analgesic requirement [ Time Frame: During 1 hour at PACU ]
  2. duration of analgesic free [ Time Frame: During 1 hour at PACU ]

Secondary Outcome Measures :
  1. analgesic requirement [ Time Frame: During 8 hours after arriving at ward ]
  2. Pain on the VAS scale [ Time Frame: During 1 hour at PACU ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493231


Contacts
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Contact: Mi hyun Lee +82-02-829-5230 md1212@naver.com

Locations
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Korea, Republic of
Hallym University Kangnam Sacred Heart Hospita Recruiting
Seoul, Korea, Republic of
Contact: Haejin Son    +82-02-829-5527    dandelionc@hallym.or.kr   
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital

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Responsible Party: Lee Mi Hyeon, assistant professor, Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02493231     History of Changes
Other Study ID Numbers: 2014-10-133
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Ketamine
Nefopam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic