Remifentanil for the I-gel and Laryngeal Mask Airway Insertion

Phase 4

Completed

• Conditions: Supraglottic Airways for General Anesthesia
• Interventions: Drug: remifentanil; Device: i-gel; Device: laryngeal mask airway; Drug: propofol

• Registration Number: NCT02382354
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

Structural differences of supraglottic airway devices could influence the different compressive forces in the oropharyngeal cavities, and require different depth of anesthesia. The addition of remifentanil during propofol anesthesia facilitates the insertion of laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50) and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA insertion during propofol target-controlled infusion (TCI).

Detailed Description

Anesthesia was induced with propofol TCI at the effect-site concentration of 5 μg/ml, and the predetermined effect-site concentration of remifentanil was started simultaneously. The remifentanil concentration was determined using modified Dixon's up-and-down method (initial concentration: 3.0 ng/ml, step size: 0.5 ng/ml). Five minutes later, i- gel or LMA insertion was attempted. The response of the patients to the insertion of LMA was classified as either 'movement' or 'no movement'.

Study Timeline

• Study First Submitted: 2015-02-25
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

• ASA I-II patients undergoing general anesthesia for short elective surgery (<2 hr)

Exclusion Criteria

• G-E reflux
• obesity (BMI>30)
• anticipated difficult airway

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i-gel	i-gel	I-gel insertion was attempted during propofol and remifentanil anesthesia .
laryngeal mask airway	laryngeal mask airway	LMA insertion was attempted during propofol and remifentanil anesthesia .
laryngeal mask airway	propofol	LMA insertion was attempted during propofol and remifentanil anesthesia .
i-gel	remifentanil	I-gel insertion was attempted during propofol and remifentanil anesthesia .
i-gel	propofol	I-gel insertion was attempted during propofol and remifentanil anesthesia .
laryngeal mask airway	remifentanil	LMA insertion was attempted during propofol and remifentanil anesthesia .

Primary Outcome Measures

Name	Time	Method
successful insertion of i-gel and LMA	from 5 min after anesthetic induction to 1min after device insertion

Trial Locations

Locations (1)

Ajou University hospital; 🇰🇷 Suwon, Korea, Republic of