NCT01880931

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

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

June 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

1.4 years

First QC Date

June 16, 2013

Last Update Submit

April 8, 2015

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

  • The effect site concentration of remifentanil for preventing QTc interval prolongation

    2 min

Study Arms (2)

Normotensive patients

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

Hypertensive patients

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

Hypertensive patientsNormotensive patients

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 50 years ASA class I-II female who received surgery with endotracheal intubation

You may not qualify if:

  • emergency surgery electrocardiography abnormality 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, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 16, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

KR(1)