Effect of Intraoperative Nefopam on Acute Pain After Remi... | NCT02493231

Studies
Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

NCT02493231

Sponsor

Hallym University Kangnam Sacred Heart Hospital

Status

Unknown status

Last Update Posted

Sep 2, 2015Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Cholecystitis

Interventions

Nefopam
Ketamine
Saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Jul 2, 2015

First Submission Date that Met QC Criteria

Jul 6, 2015

First Posted Date

Jul 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2015

Last Update Posted Date

Sep 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lee Mi Hyeon, assistant professor, Hallym University Kangnam Sacred Heart HospitalPrincipal Investigator

Lead Sponsor

Hallym University Kangnam Sacred Heart HospitalOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nefopam	Active Comparator	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
Ketamine	Active Comparator	It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr	Drug: Ketamine
Saline	Placebo Comparator	It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nefopam	Drug		Nefopam
Ketamine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mi hyun Lee	Contact	+82-02-829-5230		md1212@naver.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Kangnam Sacred Heart Hospita	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009340	Nefopam
D007649	Ketamine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D010079	Oxazocines
D001392	Azocines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided