Dosing Study of Remifentanil for Smooth Removal of the Laryngeal Mask Airway (LMA)

Drug Usage Clinical Trial

Official title:

Effect-site Concentration of Remifentanil for Smooth Removal of the LMA From Propofol Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931683
• Other study ID #: AJIRB-MED-CT4-13
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2013
• Last updated: October 13, 2014
• Start date: October 2013
• Est. completion date: February 2014

Study information

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

Clinical Trial Summary

The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia.

Description:

At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). LMA removal was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I-II patients undergoing general anesthesia for short elective surgery (<1 hr)

Exclusion Criteria:

• G-E reflux

• obesity (BMI>30)

• anticipated difficult airway

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Usage

Intervention

Drug:
• remifentanil
The concentration of remifentanil was determined by modified Dixon's up-and-down method, starting from 1.0 ng/ml (0.2 ng/ml as a step size)

Device:
• laryngeal mask airway (LMA)
LMA was removed when the patients opened their eyes, and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smooth removal of LMA	the response of patients to the removal of LMA (classified as either 'success [smooth emergence]' or 'failure') during infusion of remifentanil.	from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).	Yes