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NCT02493231 Clinical Trial

Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

Cholecystitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02493231
Other study ID # 2014-10-133
Secondary ID
Status Recruiting
Phase Phase 4
First received July 2, 2015
Last updated August 31, 2015
Start date March 2015

Study information
Verified date August 2015
Source Hallym University Kangnam Sacred Heart Hospital
Contact Mi hyun Lee
Phone +82-02-829-5230
Email md1212@naver.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Nefopam

• Ketamine

• Saline

Locations
Country Name City State
Korea, Republic of Hallym University Kangnam Sacred Heart Hospita Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary analgesic requirement During 1 hour at PACU No
Primary duration of analgesic free During 1 hour at PACU No
Secondary analgesic requirement During 8 hours after arriving at ward No
Secondary Pain on the VAS scale During 1 hour at PACU No
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