Thyroid NeoplasmPhase 4NCT01308320
Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
A Phase 4 study testing fentanyl citrate and saline in people with Thyroid Neoplasm, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 years, women only
- Conditions the study is for
- Thyroid Neoplasm
- What is being tested?
- fentanyl citrate and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
- ASA I-II.
- 20-59 years old.
- female only.
Who cannot join
- signs of difficult intubation.
- risks for perioperative pulmonary aspiration.
- history of chronic respiratory disease.
- recent upper respiratory track infection.
- previous and recent smoking history
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Thyroid Neoplasm
- Being tested
- fentanyl citrate, saline
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl citrateDrug
According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.
salineDrug
According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| saline | Placebo comparator | control group Receives: Drug: saline |
| F1 group | Active comparator | F1 group : fentanyl 1 mcg/kg Receives: Drug: fentanyl citrate |
| F1.5 group | Active comparator | F1.5 group : fentanyl 1.5 mcg/kg Receives: Drug: fentanyl citrate |
| F2 group | Active comparator | F2 group : fentanyl 2 mcg/kg Receives: Drug: fentanyl citrate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308320
- Sponsor's protocol ID
- 4-2009-0111
- Status last verified
- Mar 2011
- First submitted
- 3 Mar 2011
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9637637Nishina 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.
PubMed 7725888
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
- ClinicalTrials.gov ID
- NCT01308320
- Acronym / sponsor ID
- 4-2009-0111
- Conditions
- Thyroid Neoplasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| saline | Placebo comparator | Drug: salinecontrol group |
| F1 group | Active comparator | Drug: fentanyl citrateF1 group : fentanyl 1 mcg/kg |
| F1.5 group | Active comparator | Drug: fentanyl citrateF1.5 group : fentanyl 1.5 mcg/kg |
| F2 group | Active comparator | Drug: fentanyl citrateF2 group : fentanyl 2 mcg/kg |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
- ASA I-II.
- 20-59 years old.
- female only.
Key exclusion criteria (5 listed)
- signs of difficult intubation.
- risks for perioperative pulmonary aspiration.
- history of chronic respiratory disease.
- recent upper respiratory track infection.
- previous and recent smoking history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanyl citrateAccording to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation. | Drug | F1 group, F1.5 group, F2 group |
| salineAccording to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation. | Drug | saline |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
- Background: PubMed 9637637Tagaito 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.
- Background: PubMed 7725888Nishina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fentanyl citrate and saline in people with Thyroid Neoplasm, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01308320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2011.