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Remifentanil for Smooth Emergence in Elderly Patients

NCT ID: NCT02334046

Last Updated: 2015-12-18

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

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anaesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing cough during emergence in elderly patients under sevoflurane and remifentanil anesthesia.

Detailed Description

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Conditions

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Drug Usage

Keywords

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tracheal extubation remifentanil

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Elderly

Remifentanil was maintained at predetermined effect-site concentration during the emergence period in elderly patients.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in adult patients (20-60 years) .

Sevoflurane

Intervention Type DRUG

Anesthesia was maintained with sevoflurane with 1.5-2.0 vol% in air/50%oxygen mixture, and sevoflurane was adjusted to about 1.0 vol% 10 min before end of surgery.

Adult

Remifentanil was maintained at predetermined effect-site concentration during the emergence period in adult patients.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in elderly patients (65-80 years) .

Sevoflurane

Intervention Type DRUG

Anesthesia was maintained with sevoflurane with 1.5-2.0 vol% in air/50%oxygen mixture, and sevoflurane was adjusted to about 1.0 vol% 10 min before end of surgery.

Interventions

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Remifentanil

Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in elderly patients (65-80 years) .

Intervention Type DRUG

Remifentanil

Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in adult patients (20-60 years) .

Intervention Type DRUG

Sevoflurane

Anesthesia was maintained with sevoflurane with 1.5-2.0 vol% in air/50%oxygen mixture, and sevoflurane was adjusted to about 1.0 vol% 10 min before end of surgery.

Intervention Type DRUG

Other Intervention Names

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Ultiva Ultiva

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under balanced anesthesia with sevoflurane and remifentanil

Exclusion Criteria

* predicted difficult airway, body mass index \> 30 kg/m2, history of obstructive sleep apnoea chronic respiratory disease or coughing, current smokers patients angiotensin converting enzyme-inhibitors
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 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

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Yeop Kim

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou University Hospital

Suwon, Gyeongki-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-CT4-14-383

Identifier Type: -

Identifier Source: org_study_id