search
Back to results

Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

Primary Purpose

Cholecystitis

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nefopam
Ketamine
Saline
Sponsored by
Hallym University Kangnam Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholecystitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Hallym University Kangnam Sacred Heart HospitaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Nefopam

Ketamine

Saline

Arm 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

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

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

Outcomes

Primary Outcome Measures

analgesic requirement
duration of analgesic free

Secondary Outcome Measures

analgesic requirement
Pain on the VAS scale

Full Information

First Posted
July 2, 2015
Last Updated
August 31, 2015
Sponsor
Hallym University Kangnam Sacred Heart Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02493231
Brief Title
Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nefopam
Arm Type
Active Comparator
Arm 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
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr
Intervention Type
Drug
Intervention Name(s)
Nefopam
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
analgesic requirement
Time Frame
During 1 hour at PACU
Title
duration of analgesic free
Time Frame
During 1 hour at PACU
Secondary Outcome Measure Information:
Title
analgesic requirement
Time Frame
During 8 hours after arriving at ward
Title
Pain on the VAS scale
Time Frame
During 1 hour at PACU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mi hyun Lee
Phone
+82-02-829-5230
Email
md1212@naver.com
Facility Information:
Facility Name
Hallym University Kangnam Sacred Heart Hospita
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haejin Son
Phone
+82-02-829-5527
Email
dandelionc@hallym.or.kr

12. IPD Sharing Statement

Learn more about this trial

Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

We'll reach out to this number within 24 hrs