Obstructive Sleep ApneaNCT02484222
Fentanyl Test in Children's Adenotonsillectomy
An observational study of Obstructive Sleep Apnea, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The purpose of this study is to discuss the relationship between the result of fentanyl test and required dosage of morphine for children with OSAS after adenotonsillectomy；and to evaluate the ability of predicting requested dosage of morphine postoperatively. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Fentanyl
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children who were diagnosed with Obstructive Sleep Apnea Syndrome(OSAS) by electronic nasopharyngoscope and underwent selective adenotonsillectomy
Who may be able to join
- the American society of anesthesiologists (ASA) class Ⅰ ~ Ⅱ
- the age of 3 ~ 7 years old
- children who underwent selective adenotonsillectomy.
Who cannot join
- craniofacial malformations
- mental retardation
- BMI > 22 kg/m2
- a history of bronchial asthma
- a recent history of opioid use.
Trial locations and contacts
1 site in 1 country.
China1 site
Chilren's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Fentanyl Test Results and Its Association With Morphine Requirements in Children With Obstructive Sleep Apnea Syndrome After Adenotonsillectomy
The purpose of this study is to discuss the relationship between the result of fentanyl test and required dosage of morphine for children with OSAS after adenotonsillectomy；and to evaluate the ability of predicting requested dosage of morphine postoperatively.
Read the detailed description
All the patients were intubated. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. All the patients were given morphine for pain relief according to our protocol after extubation.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Fentanyl
- Keywords
- adenotonsillectomy, fentanyl
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Fentanyl test
Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue Morphine Requirement
Measured: average 1 hour from extubation
Secondary outcomes (2)
Post-operative Nausea and Vomiting
Measured: average 1 hour from extubation
Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent
Measured: average 1 hour from extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuan Wang, Children's Hospital of Fudan University
- Investigators
- Xuan Wang, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484222
- Sponsor's protocol ID
- FTCA-01
- Status last verified
- Jun 2019
- First submitted
- 16 Jun 2015
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li YH, Wang X, Zhou ZJ, Zhuang PJ. Association between fentanyl test results and rescue morphine requirements in children after adenotonsillectomy. J Anesth. 2018 Feb;32(1):77-81. doi: 10.1007/s00540-017-2433-0. Epub 2017 Nov 21.
PubMed 29164334
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Test Results and Its Association With Morphine Requirements in Children With Obstructive Sleep Apnea Syndrome After Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT02484222
- Acronym / sponsor ID
- FTCA-01
- Conditions
- Obstructive Sleep Apnea
- Keywords
- adenotonsillectomy, fentanyl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to discuss the relationship between the result of fentanyl test and required dosage of morphine for children with OSAS after adenotonsillectomy；and to evaluate the ability of predicting requested dosage of morphine postoperatively.
Detailed description
All the patients were intubated. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. All the patients were given morphine for pain relief according to our protocol after extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children who were diagnosed with Obstructive Sleep Apnea Syndrome(OSAS) by electronic nasopharyngoscope and underwent selective adenotonsillectomy
Key inclusion criteria (3 listed)
- the American society of anesthesiologists (ASA) class Ⅰ ~ Ⅱ
- the age of 3 ~ 7 years old
- children who underwent selective adenotonsillectomy.
Key exclusion criteria (5 listed)
- craniofacial malformations
- mental retardation
- BMI > 22 kg/m2
- a history of bronchial asthma
- a recent history of opioid use.
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 |
|---|---|---|
| FentanylAlso: Fentanyl testBefore the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. | Drug | – |
Primary outcome
Rescue Morphine Requirement
Time frame: average 1 hour from extubation
2 secondary outcomes
Post-operative Nausea and Vomiting
Time frame: average 1 hour from extubation
Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent
Time frame: average 1 hour from extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29164334Li YH, Wang X, Zhou ZJ, Zhuang PJ. Association between fentanyl test results and rescue morphine requirements in children after adenotonsillectomy. J Anesth. 2018 Feb;32(1):77-81. doi: 10.1007/s00540-017-2433-0. Epub 2017 Nov 21.
- Individual participant dataSharing planned: No
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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.
Xuan Wang principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Children's Hospital of Fudan University at 1 site in China.
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 3 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 9 Jul 2019. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Rescue Morphine Requirement (time frame: average 1 hour from extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484222, which also lists 1 linked publication.
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 9 Jul 2019.