Trial Outcomes & Findings for Effect-site Concentration of Propofol for I-gel Insertion During Anesthesia Induction With a Single-dose Dexmedetomidine (NCT NCT02268656)

Results Overview

effect site concentration of propofol

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

from i-gel insertion up to 5 min

Results posted on

2022-08-03

Participant Flow

There was no one who was excluded from the study before and after assignment to groups

Participant milestones

Participant milestones
Measure	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 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	Concentraion of Propofol Infemale 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
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concentration in Male n=20 Participants 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	Concentraion in Female n=20 Participants 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	Total n=40 Participants Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 11 • n=5 Participants	35 years STANDARD_DEVIATION 9 • n=7 Participants	35 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	0 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment South Korea	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: from i-gel insertion up to 5 min

Population: Patients who infused dexmedetomidine and propofol for anesthesia

effect site concentration of propofol

Outcome measures

Outcome measures
Measure	Concentration in Male n=20 Participants 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	Concentraion in Female n=20 Participants 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
Concentration of Propofol	5.46 ug/ml Standard Deviation 0.26	3.82 ug/ml Standard Deviation 0.34

Adverse Events

Concentration in Male

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Concentraion in Female

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Concentration in Male n=20 participants at risk 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	Concentraion in Female n=20 participants at risk 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
General disorders bradycardia	5.0% 1/20 • Number of events 1 • During administration of study drugs approximately 5 minutes Adverse Events that were monitored for systematically were hypotension, hypertension, bradycardia, and other mild / serious adverse event including all cause of mortality	0.00% 0/20 • During administration of study drugs approximately 5 minutes Adverse Events that were monitored for systematically were hypotension, hypertension, bradycardia, and other mild / serious adverse event including all cause of mortality
General disorders hypertension	0.00% 0/20 • During administration of study drugs approximately 5 minutes Adverse Events that were monitored for systematically were hypotension, hypertension, bradycardia, and other mild / serious adverse event including all cause of mortality	5.0% 1/20 • Number of events 1 • During administration of study drugs approximately 5 minutes Adverse Events that were monitored for systematically were hypotension, hypertension, bradycardia, and other mild / serious adverse event including all cause of mortality

Additional Information

Dr. Hyun Jeong Kwak

Gil hospital

Phone: 82324603636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place