Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

NCT ID: NCT01308320

Last Updated: 2011-03-04

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-07-31

Brief Summary

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Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia.

Detailed Description

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Conditions

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Thyroid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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saline

control group

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.

F1 group

F1 group : fentanyl 1 mcg/kg

Group Type ACTIVE_COMPARATOR

fentanyl citrate

Intervention Type DRUG

According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.

F1.5 group

F1.5 group : fentanyl 1.5 mcg/kg

Group Type ACTIVE_COMPARATOR

fentanyl citrate

Intervention Type DRUG

According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.

F2 group

F2 group : fentanyl 2 mcg/kg

Group Type ACTIVE_COMPARATOR

fentanyl citrate

Intervention Type DRUG

According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.

Interventions

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fentanyl citrate

According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.

Intervention Type DRUG

saline

According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
* ASA I-II.
* 20-59 years old.
* female only.

Exclusion Criteria

* signs of difficult intubation.
* risks for perioperative pulmonary aspiration.
* history of chronic respiratory disease.
* recent upper respiratory track infection.
* previous and recent smoking history
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Severance Hospital, Department of Anesthesiology and Pain Medicine in Yonsei University College of Medicine

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.

Reference Type BACKGROUND
PMID: 9637637 (View on PubMed)

Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.

Reference Type BACKGROUND
PMID: 7725888 (View on PubMed)

Other Identifiers

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4-2009-0111

Identifier Type: -

Identifier Source: org_study_id

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