NCT01240109

Brief Summary

The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

4 months

First QC Date

November 10, 2010

Last Update Submit

May 12, 2011

Conditions

Study Arms (2)

propofol

ACTIVE COMPARATOR
Drug: Remifentanil

sevoflurane

ACTIVE COMPARATOR
Drug: Remifentanil

Interventions

* propofol group : propofol effect site-TCI 2-4mcg/ml + remifentanil effect site-TCI 2-4ng/ml * sevoflurane group: sevoflurane end-tidal concentration 0.5-1.0 MAC + remifentanil effect site-TCI 2-4ng/ml

Also known as: Ultiva
propofolsevoflurane

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • females
  • ASA I-II
  • aged between 20 and 70 year
  • general anesthesia for elective thyroidectomy

You may not qualify if:

  • signs of an anatomical or functional abnormality in upper airway
  • risk factors for perioperative aspiration
  • smoking for recent 8 weeks
  • URI or sore throat for recent 2 weeks
  • potential of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jeong-Rim Lee, MD, Ph.D

    Severance Hospital, Department of Anesthesiology and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 15, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations