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

Not Applicable

Completed

• Conditions: Respiratory Complication
• Interventions: Drug: Remifentanil

• Registration Number: NCT01915108
• Lead Sponsor: Sangjin Park

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Results First Submitted: 2014-07-13
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Results First Posted: 2014-08-25
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group R1.0	Remifentanil	remifentanil Ce of 1.0 ng/ml
group R0.5	Remifentanil	remifentanil Ce of 0.5 ng/ml
group R1.5	Remifentanil	remifentanil Ce of 1.5 ng/ml

Primary Outcome Measures

Name	Time	Method
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.