Reduction of Remifentanil-related Complications | NCT01003028

Studies
Reduction of Remifentanil-related Complications

NCT01003028

Sponsor

Seoul National University Hospital

Status

Not yet recruiting

Last Update Posted

Dec 1, 2023Actual

Enrollment

160Estimated

Phase

Phase 4

Conditions

Anesthesia

Interventions

Remifentanil (Limited) - Target Controlled Infusion system
Remifentanil (Control) - Target Controlled Infusion system

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Oct 23, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

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

Nov 29, 2023

Last Update Posted Date

Dec 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chul-Woo Jung, Assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.

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

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Limited	Experimental	Limit the maximum plasma concentration target to 9.8 ng/ml	Drug: Remifentanil (Limited) - Target Controlled Infusion system
Control	Active Comparator	Use 20 ng/ml as max plasma concentration	Drug: Remifentanil (Control) - Target Controlled Infusion system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remifentanil (Limited) - Target Controlled Infusion system	Drug	Limit max plasma concentration to 9.8 ng/ml	Limited

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hypotension more than 25% from baseline		during remifentanil loading

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-70 year old
ASA class 1-3 scheduled for elective surgery

Exclusion Criteria:

history of neurologic or mental disorder
uncontrolled pulmonary or cardiovascular disease
history of adverse reactions to opioids
history of drug abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ho Geol Ryu, MD, PhD	Contact	82-17-259-9173		hogeol@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077208	Remifentanil

Ancestor Terms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided