NCT02268656

Brief Summary

Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI) pump. Effect site concentraion of propofol start from 5 and changes the concentration as previous response to i-gel insertion as up and down methods

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

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

October 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

August 3, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

October 9, 2014

Results QC Date

February 14, 2019

Last Update Submit

August 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concentration of Propofol

    effect site concentration of propofol

    from i-gel insertion up to 5 min

Study Arms (2)

concentration of propofol in male

OTHER

after infusion of dexmedetomidine dexmedetomidine 0.5 mcg/kgfor 2 min, infusion of propofol as using target controlled infusion pump. Effect site concentration would be changed as the response to i-gel insertion as up and down method in male

Drug: propofol concentration

concentration of propofol in female

OTHER

after infusion of dexmedetomidine dexmedetomidine 0.5 mcg/kgfor 2 min, infusion of propofol as using target controlled infusion pump. Effect site concentration would be changed as the response to i-gel insertion as up and down method in female

Drug: propofol concentration

Interventions

First subjects start from effect site concentraion of 5ug/ml propofol, after insertion of i-gel, determine the next subjects' effect site concentraion would be increae or decrease 0.5 ug/ml as up and down method

Also known as: up and down method
concentration of propofol in femaleconcentration of propofol in male

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA PS I-II, 20-60 yrs old

You may not qualify if:

  • predicted difficulty airway, recent URI, BMI \> 30kg/m2, reactive airway disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Choi JJ, Kim JY, Lee D, Chang YJ, Cho NR, Kwak HJ. Male patients require higher optimal effect-site concentrations of propofol during i-gel insertion with dexmedetomidine 0.5 mug/kg. BMC Anesthesiol. 2016 Mar 22;16:20. doi: 10.1186/s12871-016-0186-1.

MeSH Terms

Conditions

Ige Responsiveness, Atopic

Results Point of Contact

Title
Dr. Hyun Jeong Kwak
Organization
Gil hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 20, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 3, 2022

Results First Posted

August 3, 2022

Record last verified: 2022-08