Respiratory Complication
Conditions
Brief summary
This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence.
Detailed description
Patients were randomly assigned to one of four groups. All patients received a predetermined effect-site concentrations (Ce) of remifentanil by target-controlled infusion (TCI) according to their group assignments (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml) from 10 minutes before the end of surgery to LMA removal. Airway complications (airway obstruction, desaturation, breath holding, and coughing), nausea, and vomiting were assessed during the emergence phase.
Interventions
DRUGRemifentanil
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Sponsors
Sangjin Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status 1 or 2 * undergoing lower extremity surgery under general anesthesia
Exclusion criteria
* suspected difficult airways * respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection) * body mass index \> 30 kg/m2 * allergies to the study drugs * a history of gastric reflux
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events Following LMA Removal | from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes. | All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group R0 remifentanil Ce of 0 ng/ml | 30 |
| Group R0.5 remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml). | 29 |
| Group R1.0 remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml). | 31 |
| Group R1.5 remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml). | 30 |
| Total | 120 |
Baseline characteristics
| Characteristic | Group R0 | Group R0.5 | Group R1.0 | Group R1.5 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 29 Participants | 31 Participants | 30 Participants | 120 Participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 16 Participants | 15 Participants | 62 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 15 Participants | 15 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 30 | 6 / 30 | 14 / 29 | 3 / 31 |
| serious Total, serious adverse events | 1 / 30 | 1 / 30 | 0 / 29 | 0 / 31 |
Outcome results
Primary
Number of Patients With Adverse Events Following LMA Removal
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.
Time frame: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group R0 | Number of Patients With Adverse Events Following LMA Removal | 10 participants |
| Group R0.5 | Number of Patients With Adverse Events Following LMA Removal | 5 participants |
| Group R1.0 | Number of Patients With Adverse Events Following LMA Removal | 1 participants |
| Group R1.5 | Number of Patients With Adverse Events Following LMA Removal | 0 participants |