Trial Outcomes & Findings for Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil (NCT NCT01456299)

Results Overview

The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

at that time on LMA insertion only

Results posted on

2019-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Remifentanil 1 The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml control: Patients received a normal saline only	Control The control group, which received an infusion of normal saline remifentanil 1: The patients received an infusion of remifentanil	Remifentanil 2 The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml remifentanil 2: Patients received no remifentanil
Overall Study STARTED	34	34	34
Overall Study COMPLETED	34	33	33
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=33 Participants The control group, which received an infusion of normal saline remifentanil 1: The patients received an infusion of remifentanil	Remifentanil 1 n=34 Participants The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml control: Patients received a normal saline only	Remifentanil 2 n=33 Participants The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml remifentanil 2: Patients received no remifentanil	Total n=100 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 11 • n=5 Participants	37 years STANDARD_DEVIATION 12 • n=7 Participants	38 years STANDARD_DEVIATION 11 • n=5 Participants	38 years STANDARD_DEVIATION 11 • n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	100 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	18 Participants n=5 Participants	60 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	40 Participants n=4 Participants
Region of Enrollment Korea, Republic of	33 participants n=5 Participants	34 participants n=7 Participants	33 participants n=5 Participants	100 participants n=4 Participants

PRIMARY outcome

Timeframe: at that time on LMA insertion only

The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.

Outcome measures

Outcome measures
Measure	Remifentanil 1 n=34 Participants The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml control: Patients received a normal saline only	Remifentanil 2 n=33 Participants The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml remifentanil 2: Patients received no remifentanil	Control n=33 Participants The control group, which received an infusion of normal saline remifentanil 1: The patients received an infusion of remifentanil
LMA Insertion Condition Excellent	21 participants	24 participants	14 participants
LMA Insertion Condition Intermediate	5 participants	3 participants	7 participants
LMA Insertion Condition Poor	8 participants	6 participants	12 participants

SECONDARY outcome

Timeframe: baseline, 30sec after drug injection

If prolonged apnoea (\> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Remifentanil 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Remifentanil 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Kim

Ajou University

Phone: 82-32-460-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place