NCT01003028

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
4mo left

Started Nov 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

October 23, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
15 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

October 23, 2009

Last Update Submit

November 29, 2023

Conditions

Anesthesia

Keywords

Total intravenous anesthesiaMaximum plasma concentration of remifentanil

Outcome Measures

Primary Outcomes (1)

  • hypotension more than 25% from baseline

    during remifentanil loading

Study Arms (2)

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

Remifentanil (Limited) - Target Controlled Infusion systemDRUG

Limit max plasma concentration to 9.8 ng/ml

Limited
Remifentanil (Control) - Target Controlled Infusion systemDRUG

Use 20 ng/ml as max plasma concentration

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year old
  • ASA class 1-3 scheduled for elective surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Ho Geol Ryu, MD, PhD

CONTACT

82-17-259-9173hogeol@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 28, 2009

Study Start

November 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

KR(1)