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Completed

NCT Number: NCT01456299

Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

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Key information

Conditions

Laryngismus Laryngeal Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Tract Diseases Vocal Cord Dysfunction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University School of Medicine

Suwon, South Korea

About this study

For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study

Exclusion criteria

  • Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway

Treatment and study plan

Remifentanil 1

Drug

"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.

Other names: R1

Control

Drug

The control group, which received an infusion of normal saline

Other names: Placebo

Remifentanil 2

Drug

"Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.

Other names: R2

Primary outcomes

  1. LMA Insertion Condition

    Time frame: at that time on LMA insertion only

    The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.

Secondary outcomes

  1. Frequency of Apnea

    Time frame: baseline, 30sec after drug injection

    If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

Target-controlled Infusion of Remifentanil for Laryngeal Mask Airway Insertion During Sevoflurane Induction in Adults

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2011
Registry last updated
Mar 15, 2019

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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