Igel
Conditions
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
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.
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
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ASA PS I-II, 20-60 yrs old
Exclusion criteria
* predicted difficulty airway, recent URI, BMI \> 30kg/m2, reactive airway disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Propofol | from i-gel insertion up to 5 min | effect site concentration of propofol |
Participant flow
Pre-assignment details
There was no one who was excluded from the study before and after assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| Concentration 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
propofol: 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 | 20 |
| Concentraion 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
propofol: 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 | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Concentration in Male | Concentraion in Female | Total |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 11 | 35 years STANDARD_DEVIATION 9 | 35 years STANDARD_DEVIATION 10 |
| Region of Enrollment South Korea | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 0 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Male | 20 Participants | 0 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Concentration of Propofol
effect site concentration of propofol
Time frame: from i-gel insertion up to 5 min
Population: Patients who infused dexmedetomidine and propofol for anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Concentration in Male | Concentration of Propofol | 5.46 ug/ml | Standard Deviation 0.26 |
| Concentraion in Female | Concentration of Propofol | 3.82 ug/ml | Standard Deviation 0.34 |