EC95 of Remifentanil for Preventing Cough

NCT ID: NCT02973724

Last Updated: 2017-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-06-30

Brief Summary

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The investigator designed this study to investigate remifentanil effect-site concentration in 95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol anesthesia.

Detailed Description

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At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Conditions

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Drug Usage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remifentanil

Extubation was performed when remifentanil was maintained a predetermined concentration throughout the emergence periods.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)

Propofol anesthesia

Intervention Type DRUG

Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.

Interventions

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Remifentanil

The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)

Intervention Type DRUG

Propofol anesthesia

Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.

Intervention Type DRUG

Other Intervention Names

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Ultiva Fresofol

Eligibility Criteria

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Inclusion Criteria

* ASA I-II patients undergoing general anesthesia for laryngomicrosurgery

Exclusion Criteria

* Anticipated difficult airway
* COPD, Asthma
* Recent URI (\< 2 weeks)
* Severe cardiac, hepatic renal disease
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jong Yeop Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-CT4-16-349

Identifier Type: -

Identifier Source: org_study_id

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