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

Primary Purpose

Thyroid Neoplasm

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

fentanyl citrate

saline

About this trial

This is an interventional supportive care trial for Thyroid Neoplasm

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

saline

F1 group

F1.5 group

F2 group

Arm Description

control group

F1 group : fentanyl 1 mcg/kg

F1.5 group : fentanyl 1.5 mcg/kg

F2 group : fentanyl 2 mcg/kg

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01308320

First Posted

March 3, 2011

Last Updated

March 3, 2011

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01308320

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Neoplasm

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

saline

Arm Type

Placebo Comparator

Arm Description

control group

Arm Title

F1 group

Arm Type

Active Comparator

Arm Description

F1 group : fentanyl 1 mcg/kg

Arm Title

F1.5 group

Arm Type

Active Comparator

Arm Description

F1.5 group : fentanyl 1.5 mcg/kg

Arm Title

F2 group

Arm Type

Active Comparator

Arm Description

F2 group : fentanyl 2 mcg/kg

Intervention Type

Drug

Intervention Name(s)

fentanyl citrate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

saline

Intervention Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

9637637

Citation

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.

Results Reference

background

PubMed Identifier

7725888

Citation

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.

Results Reference

background

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

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