NCT01084031

Brief Summary

Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.

Trial Health

100
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 Nov 2009

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

November 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

3 months

First QC Date

March 5, 2010

Last Update Submit

February 17, 2014

Conditions

Pediatric Urinary Disorders

Outcome Measures

Primary Outcomes (1)

  • Assessment of intubation conditions

    Assessment of intubation conditions (vocal cord, intubation condition, cough, movement) , peri-induction HR and BP change, post-operative agitation socre at recovery room. ED50 and ED 95 of each group by uring Dixon's up and down methods. peri -induction period -comparison of above factors among each groups (GroupA: ETSevo 3vol%, Group B: ETSevo 3.5vol%, Group: ET Sevo 4vol%)

    30 minutes after the surgery

Study Arms (1)

propofol

EXPERIMENTAL
Drug: propofol

Interventions

propofolDRUG

intravenous propofol with sevoflurane inhalation induction

propofol

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients scheduled for elective day case surgery were enrolled.

You may not qualify if:

  • History of obstructive sleep apnea
  • Evidence of cardiorespiratory disease
  • Those who were obese or allergic to any of the anesthetic agents in this study
  • Those with an anticipated difficult airway, full stomach
  • History of malignant hyperthermia or other myopathy were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Hae Keum Kil

    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2010

First Posted

March 10, 2010

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

March 1, 2011

Last Updated

February 19, 2014

Record last verified: 2014-02