NCT01720498

Brief Summary

To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

October 31, 2012

Last Update Submit

June 16, 2013

Conditions

General Surgery With Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • The effect site concentration for preventing QTc interval prolongation

    2 min

Study Arms (2)

Male

EXPERIMENTAL

To find out the effect site concentration of remifentanil for preventing QTc prolongation \< 15 sec during intubation : Dixon's up-and-down method

Drug: remifentanil

Female

EXPERIMENTAL

To find out the effect site concentration of remifentanil for preventing QTc prolongation \< 15 sec during intubation : Dixon's up-and-down method

Drug: remifentanil

Interventions

remifentanilDRUG

The effect site concentration of remifentanil

FemaleMale

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 65 years ASA class I-II who received surgery with endotracheal intubation

You may not qualify if:

  • emergency surgery
  • electrocardiography abnormality
  • hypertension
  • diabetes mellitus
  • end stage renal disease
  • moderate to severe cardiac disease
  • moderate to severe liver dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • So Yeon Kim, MD, PhD

    Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 2, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

KR(1)