CClinicalTrials.gg
CompletedNCT02268656D-pofolUpdated Aug 3, 2022Results posted

Effect-site Concentration of Propofol for I-gel Insertion During Anesthesia Induction With a Single-dose Dexmedetomidine

An interventional study of propofol concentration in Igel, sponsored by Gachon University Gil Medical Center. Completed. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by Gachon University Gil Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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

Read the detailed description

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. Failure of previous subjects are defined as difficulty to mouth open, severe nausea and couph and laryngeal spasm, and not loss of consciousness.

02

Conditions studied

  • Igel
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA PS I-II, 20-60 yrs old

Exclusion criteria

Exclusion Criteria:

  • predicted difficulty airway, recent URI, BMI > 30kg/m2, reactive airway disease
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (actual)

Study arms

  • Other
    concentration of propofol in male

    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

  • Other
    concentration of propofol in female

    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

  • Drugpropofol concentration

    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

05

What researchers measure

Primary outcomes

  1. Concentration of Propofol

    effect site concentration of propofol

    Time frame: from i-gel insertion up to 5 min

06

Results

Posted Aug 3, 2022

Participant flow

Participant flow — Overall Study
MilestoneConcentration of Propofol in MaleConcentraion of Propofol Infemale
Started2020
Completed2020
Not completed00

Outcome measures

PrimaryConcentration of Propofol

effect site concentration of propofol

Time frame:
from i-gel insertion up to 5 min
Reported as:
Mean · ug/ml
Concentration of Propofol
ug/mlConcentration in MaleConcentraion in Female
Concentration of Propofol5.46 ± 0.263.82 ± 0.34

Adverse events

Collected over During administration of study drugs approximately 5 minutes. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Concentration in Male0/20 (0%)0/20 (0%)1/20 (5%)
Concentraion in Female0/20 (0%)0/20 (0%)1/20 (5%)
Most frequent other events
Most frequent other events
EventConcentration in MaleConcentraion in Female
bradycardiaGeneral disorders1/200/20
hypertensionGeneral disorders0/201/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Concentration in MaleConcentraion in FemaleTotal
Mean35 ± 1135 ± 935 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)Concentration in MaleConcentraion in FemaleTotal
Female02020
Male20020
Region of Enrollment
Region of Enrollment(participants)Concentration in MaleConcentraion in FemaleTotal
South Korea202040
07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27004426 ↗
09

Registry details

Key details

Study ID
NCT02268656
Lead sponsor
Gachon University Gil Medical Center
Responsible party
Youn Yi Jo (Assistant professor, Gachon University Gil Medical Center) — Principal investigator
First posted
Oct 20, 2014
Start date
Oct 2014
Primary completion
Feb 2015
Completion
Feb 2015
Results posted
Aug 3, 2022
Last update
Aug 3, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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