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

Sangjin Park

Status: Completed

Conditions: Respiratory Complication

Treatments: Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01915108

apsj1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 4 patient groups

group R0

No Intervention group

Description:

remifentanil Ce of 0 ng/ml

group R0.5

Active Comparator group

Description:

remifentanil Ce of 0.5 ng/ml

Treatment:

Drug: Remifentanil

group R1.0

Active Comparator group

Description:

remifentanil Ce of 1.0 ng/ml

Treatment:

Drug: Remifentanil

group R1.5

Active Comparator group

Description:

remifentanil Ce of 1.5 ng/ml

Treatment:

Drug: Remifentanil