Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

NCT ID: NCT01456299

Last Updated: 2019-03-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laryngismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

The control group, which received an infusion of normal saline.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

The control group, which received an infusion of normal saline

Remifentanil 1

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

Group Type ACTIVE_COMPARATOR

Remifentanil 1

Intervention Type DRUG

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

Remifentanil 2

"Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml.

Group Type ACTIVE_COMPARATOR

Remifentanil 2

Intervention Type DRUG

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

Interventions

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Remifentanil 1

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

Intervention Type DRUG

Control

The control group, which received an infusion of normal saline

Intervention Type DRUG

Remifentanil 2

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

Intervention Type DRUG

Other Intervention Names

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R1 Placebo R2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jeong Kwak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Yeop Kim, MD,PhD

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Jong Yeop Kim, MD, PhD

Role: STUDY_DIRECTOR

Ajou Universiy School of Medicine

Locations

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Ajou University School of Medicine

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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Sivalingam P, Kandasamy R, Madhavan G, Dhakshinamoorthi P. Conditions for laryngeal mask insertion. A comparison of propofol versus sevoflurane with or without alfentanil. Anaesthesia. 1999 Mar;54(3):271-6. doi: 10.1046/j.1365-2044.1999.00663.x.

Reference Type BACKGROUND
PMID: 10364865 (View on PubMed)

Other Identifiers

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AJIRB-MED-CT4-11-045

Identifier Type: REGISTRY

Identifier Source: secondary_id

AJIRB-MED-CT4-11-045

Identifier Type: -

Identifier Source: org_study_id

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