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

Respiratory Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915108
• Other study ID #: apsj1
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: August 21, 2014
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Complication

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sangjin Park

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.	Yes