Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

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 Overview

• Status: Unknown
• Conditions: Cholecystitis
• Intervention / Treatment: Drug: Saline; Drug: Ketamine; Drug: Nefopam

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mi hyun Lee; Phone Number: +82-02-829-5230; Email: md1212@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hallym University Kangnam Sacred Heart Hospita
    • Contact: Haejin Son; Phone Number: +82-02-829-5527; Email: dandelionc@hallym.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
analgesic requirement	During 1 hour at PACU
duration of analgesic free	During 1 hour at PACU

Secondary Outcome Measures

Outcome Measure	Time Frame
analgesic requirement	During 8 hours after arriving at ward
Pain on the VAS scale	During 1 hour at PACU

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Ketamine; Nefopam
• Other Study ID Numbers: 2014-10-133