Remifentanil for the I-gel and Laryngeal Mask Airway Insertion

NCT02382354 | Completed Phase 4 DMC

• 1 other identifier: AJIRB-MED-CT4-14-417
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Supraglottic Airways for General Anesthesia

Outcome Measures

Primary Outcomes (1)

• successful insertion of i-gel and LMA

  from 5 min after anesthetic induction to 1min after device insertion

Study Arms (2)

i-gel

EXPERIMENTAL

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

Drug: remifentanil; Device: i-gel; Drug: propofol

laryngeal mask airway

ACTIVE COMPARATOR

LMA insertion was attempted during propofol and remifentanil anesthesia .

Drug: remifentanil; Device: laryngeal mask airway; Drug: propofol

Interventions

remifentanil DRUG

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

Also known as: ultiva

i-gel; laryngeal mask airway

i-gel DEVICE

I-gel insertion was inserted 5 min after anesthesia induction

i-gel

laryngeal mask airway DEVICE

laryngeal mask airway insertion was inserted 5 min after anesthesia induction

laryngeal mask airway

propofol DRUG

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

Also known as: fresofol

i-gel; laryngeal mask airway

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University hospital

Suwon, 443-721, South Korea

Location

MeSH Terms

Interventions

Remifentanil; Laryngeal Masks; Propofol

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jong Yeop Kim, MD

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 6, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

KR (1)