Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

Hallym University Kangnam Sacred Heart Hospital

Status and phase: Unknown; Phase 4

Conditions: Cholecystitis

Treatments: Drug: Saline; Drug: Ketamine; Drug: Nefopam

Study type: Interventional

Funder types: Other

Identifiers

NCT02493231

2014-10-133

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Nefopam

Active Comparator group

Description:

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

Treatment:

Drug: Nefopam

Ketamine

Active Comparator group

Description:

It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr

Treatment:

Drug: Ketamine

Saline

Placebo Comparator group

Description:

It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr

Treatment:

Drug: Saline