Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

Phase 4

• Conditions: Cholecystitis
• Interventions: Drug: Ketamine; Drug: Saline; Drug: Nefopam

• Registration Number: NCT02493231
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr
Saline	Saline	It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr
Nefopam	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

Primary Outcome Measures

Name	Time	Method
duration of analgesic free	During 1 hour at PACU
analgesic requirement	During 1 hour at PACU

Secondary Outcome Measures

Name	Time	Method
analgesic requirement	During 8 hours after arriving at ward
Pain on the VAS scale	During 1 hour at PACU

Trial Locations

Locations (1)

Hallym University Kangnam Sacred Heart Hospita; 🇰🇷 Seoul, Korea, Republic of