AnesthesiaORCONCT03218124
Optimal Remifentanil Concentration and Thyroidectomy
A study testing Remifentanil Effect site concentration in people with Anesthesia, run by University of Cagliari at 1 site in Italy.
Trial summary
The study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remifentanil Effect site concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2017to 1 Jul 2018
- Phase
- Interventional
- 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 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18<age<67
- 6 hrs fasting
- American society of anesthesiology (ASA) Physical Status I o II
- Informed consent
Who cannot join
- Absence of inclusion criteria
- Use of cough suppressors, angiotensin converting enzyme-inhibitors, sedatives 4 weeks before surgery
- Arhythmia, pacemaker or unstable cardiovascular disease
- Hepatic or renal failure
- Anticipated difficulty in airways management
- Chronic obstructive pulmonary disease (COPD), Asthma, increased risk for inhalation, airway infection in the previous 4 weeks;
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- Smoker
- Obesity (BMI >35)
- Pregnancy
- Hypersensitivity to drugs administered for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery
The study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose.
Possible hemodynamic instability, respiratory depression or prolongation of awakening time are also sought.
- Conditions
- Anesthesia
- Being tested
- Remifentanil Effect site concentration
- Keywords
- Thyroidectomy, Remifentanil, Extubation, Cough, Target controlled infusion
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil Effect site concentrationOther
After skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise ("Dixon's up and down" method).
| Study group | Role | What they receive |
|---|---|---|
| remifentanil | Experimental | After skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise ("Dixon's up and down" method). Receives: Other: Remifentanil Effect site concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough
Any episode of sudden and violent abdominal contraction interrupting normal quite spontaneous or assisted ventilation would be accounted as "cough" and defines non-smooth extubation
Measured: 15 minutes after surgery
Secondary outcomes (4)
Hemodynamics 1
Heart Rate (bpm)
Measured: 15 minutes after surgery
Hemodynamics 2
Blood pressure (mmHg)
Measured: 15 minutes after surgery
Respiratory outcome 1
Tidal Volume (ml)
Measured: 15 minutes after surgery
Respiratory outcome 2
End Tidal Carbon Dioxide (mmHg)
Measured: 15 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational study. Decreasing/increasing remifentanil effect site concentrations (Dixon's up and down model) to obtain cough-free extubation after thyroidectomy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Gabriele Finco, University of Cagliari
- Investigators
- Gabriele Finco, MD, Principal investigator, Cagliari University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218124
- Sponsor's protocol ID
- Remismooth2217
- Acronym
- ORCO
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03218124
- Acronym / sponsor ID
- ORCO / Remismooth2217
- Conditions
- Anesthesia
- Keywords
- Thyroidectomy, Remifentanil, Extubation, Cough, Target controlled infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 14 Jul 2017 (actual)
- 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.
The study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose.
Possible hemodynamic instability, respiratory depression or prolongation of awakening time are also sought.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational study. Decreasing/increasing remifentanil effect site concentrations (Dixon's up and down model) to obtain cough-free extubation after thyroidectomy
| Arm | Type | Receives |
|---|---|---|
| remifentanil | Experimental | Other: Remifentanil Effect site concentrationAfter skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise ("Dixon's up and down" method). |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18<age<67
- 6 hrs fasting
- American society of anesthesiology (ASA) Physical Status I o II
- Informed consent
Key exclusion criteria (10 listed)
- Absence of inclusion criteria
- Use of cough suppressors, angiotensin converting enzyme-inhibitors, sedatives 4 weeks before surgery
- Arhythmia, pacemaker or unstable cardiovascular disease
- Hepatic or renal failure
- Anticipated difficulty in airways management
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 |
|---|---|---|
| Remifentanil Effect site concentrationAfter skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise ("Dixon's up and down" method). | Other | remifentanil |
Primary outcome
Cough
Time frame: 15 minutes after surgery
Any episode of sudden and violent abdominal contraction interrupting normal quite spontaneous or assisted ventilation would be accounted as "cough" and defines non-smooth extubation
4 secondary outcomes
Hemodynamics 1
Time frame: 15 minutes after surgery
Hemodynamics 2
Time frame: 15 minutes after surgery
Respiratory outcome 1
Time frame: 15 minutes after surgery
Respiratory outcome 2
Time frame: 15 minutes after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Gabriele Finco, MD principal investigator
Cagliari University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil Effect site concentration in people with Anesthesia, run by University of Cagliari at 1 site in Italy.
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 10 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: status not confirmed, as of the sponsor's last update on 14 Jul 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Onida, MD (+39 07051096543, paolo.onida80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough (time frame: 15 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2017.