Laryngismus
Conditions
Keywords
laryngeal mask airway, insertion, sevoflurane, remifentanil
Brief summary
The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
Detailed description
For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
Interventions
DRUGRemifentanil 1
Remifentanil 1: The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.
DRUGControl
The control group, which received an infusion of normal saline
DRUGRemifentanil 2
Remifentanil 2: The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
\- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (\< 1 h) were considered for the study
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LMA Insertion Condition | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Apnea | baseline, 30sec after drug injection | If prolonged apnoea (\> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control The control group, which received an infusion of normal saline
remifentanil 1: The patients received an infusion of remifentanil | 33 |
| Remifentanil 1 The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml
control: Patients received a normal saline only | 34 |
| Remifentanil 2 The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml
remifentanil 2: Patients received no remifentanil | 33 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control | Remifentanil 1 | Remifentanil 2 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 34 Participants | 33 Participants | 100 Participants |
| Age, Continuous | 38 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 12 | 38 years STANDARD_DEVIATION 11 | 38 years STANDARD_DEVIATION 11 |
| Region of Enrollment Korea, Republic of | 33 participants | 34 participants | 33 participants | 100 participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 18 Participants | 60 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 15 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 | 0 / 33 |
Outcome results
Primary
LMA Insertion Condition
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.
Time frame: at that time on LMA insertion only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | LMA Insertion Condition | Intermediate | 7 participants |
| Control | LMA Insertion Condition | Excellent | 14 participants |
| Control | LMA Insertion Condition | Poor | 12 participants |
| Remifentanil 1 | LMA Insertion Condition | Intermediate | 5 participants |
| Remifentanil 1 | LMA Insertion Condition | Excellent | 21 participants |
| Remifentanil 1 | LMA Insertion Condition | Poor | 8 participants |
| Remifentanil 2 | LMA Insertion Condition | Excellent | 24 participants |
| Remifentanil 2 | LMA Insertion Condition | Poor | 6 participants |
| Remifentanil 2 | LMA Insertion Condition | Intermediate | 3 participants |
Secondary
Frequency of Apnea
If prolonged apnoea (\> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group
Time frame: baseline, 30sec after drug injection