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Completed

NCT Number: NCT02382354

Remifentanil for the I-gel and Laryngeal Mask Airway Insertion

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).

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Key information

Conditions

Supraglottic Airways for General Anesthesia

Age range

19 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University hospital

Suwon, 443-721, South Korea

About this study

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'.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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

Other names: ultiva

I-gel

Device

I-gel insertion was inserted 5 min after anesthesia induction

Laryngeal mask airway

Device

laryngeal mask airway insertion was inserted 5 min after anesthesia induction

Propofol

Drug

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

Other names: fresofol

Primary outcomes

  1. successful insertion of i-gel and LMA

    Time frame: from 5 min after anesthetic induction to 1min after device insertion

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Comparison of the Effect-site Concentration of Remifentanil for Insertion of the I-gel and Laryngeal Mask Airway During Propofol Anesthesia

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2015
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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