Remifentanil for the I-gel and Laryngeal Mask Airway Insertion

NCT ID: NCT02382354

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-09-30

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'.

Conditions

Supraglottic Airways for General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

i-gel

I-gel insertion was attempted during propofol and remifentanil anesthesia .

Group Type: EXPERIMENTAL

remifentanil

Intervention Type: DRUG

The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method

i-gel

Intervention Type: DEVICE

I-gel insertion was inserted 5 min after anesthesia induction

propofol

Intervention Type: DRUG

Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml

laryngeal mask airway

LMA insertion was attempted during propofol and remifentanil anesthesia .

Group Type: ACTIVE_COMPARATOR

remifentanil

Intervention Type: DRUG

The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method

laryngeal mask airway

Intervention Type: DEVICE

laryngeal mask airway insertion was inserted 5 min after anesthesia induction

propofol

Intervention Type: DRUG

Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml

Interventions

remifentanil

The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method

Intervention Type: DRUG

i-gel

I-gel insertion was inserted 5 min after anesthesia induction

Intervention Type: DEVICE

laryngeal mask airway

laryngeal mask airway insertion was inserted 5 min after anesthesia induction

Intervention Type: DEVICE

propofol

Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml

Intervention Type: DRUG

Other Intervention Names

ultiva; fresofol

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jong Yeop Kim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong Yeop Kim, MD

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

Ajou University hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-CT4-14-417

Identifier Type: -

Identifier Source: org_study_id