Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal During Emergence From Sevoflurane-remifentanil Anesthesia

Conditions
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Respiratory Complication

Intervention / Treatment
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* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: group R0<br>remifentanil Ce of 0 ng/ml | |
| Active Comparator: group R0.5<br>remifentanil Ce of 0.5 ng/ml | Drug: Remifentanil<br>* 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).<br>* Other names: remifentanil (ultiva);|
| Active Comparator: group R1.0<br>remifentanil Ce of 1.0 ng/ml | Drug: Remifentanil<br>* 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).<br>* Other names: remifentanil (ultiva);|
| Active Comparator: group R1.5<br>remifentanil Ce of 1.5 ng/ml | Drug: Remifentanil<br>* 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).<br>* Other names: remifentanil (ultiva);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes. |