Test the Differences Between Schinder's TCI Model and MCINCT02077478
Total Intravenous Anesthesia: TCI Versus MCI
A study testing Remifentanil and propofol administration using TCI and Remifentanil and propofol administration using MCI in people with Test the Differences Between Schinder's TCI Model and MCI, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
test the following differences between Schinder's Target Controlled Infusion (TCI ) model and manually controlled infusion (MCI) : remifentanil and propofol total dose given incidence of awareness or inadequate anesthesia number of rescue dose given Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Test the Differences Between Schinder's TCI Model and MCI
- What is being tested?
- Remifentanil and propofol administration using TCI and Remifentanil and propofol administration using MCI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Sep 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing breast or thyroid surgery
Who cannot join
- BMI > 35
- Surgery shorter than 30 minutes
- Patients with history of: alcol or drug abuse, kidney or liver failure, cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Intravenous Anesthesia: TCI Versus MCI, Unresolved Question
test the following differences between Schinder's Target Controlled Infusion (TCI ) model and manually controlled infusion (MCI) :
- remifentanil and propofol total dose given
- incidence of awareness or inadequate anesthesia
- number of rescue dose given
- Being tested
- Remifentanil and propofol administration using TCI, Remifentanil and propofol administration using MCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil and propofol administration using TCIDevice
Remifentanil and propofol administration using MCIDevice
| Study group | Role | What they receive |
|---|---|---|
| MCI | Experimental | manually controlled infusion will be used Receives: Device: Remifentanil and propofol administration using MCI |
| TCI | Experimental | Target Controlled Infusion will be used Receives: Device: Remifentanil and propofol administration using TCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of awareness or inadequate anesthesia
Measured: every 3 minutes till the end of surgery
Secondary outcomes (1)
remifentanil and propofol total dose given
Measured: every 30 minutes till the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Test the Differences Between Schinder's TCI Model and MCIStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Ragazzi, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077478
- Sponsor's protocol ID
- 15022014
- Status last verified
- Sep 2014
- First submitted
- 19 Feb 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Russell D. Intravenous anaesthesia: manual infusion schemes versus TCI systems. Anaesthesia. 1998 Apr;53 Suppl 1:42-5. doi: 10.1111/j.1365-2044.1998.53s113.x.
PubMed 9640114
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Intravenous Anesthesia: TCI Versus MCI, Unresolved Question
- ClinicalTrials.gov ID
- NCT02077478
- Acronym / sponsor ID
- 15022014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Mar 2014 (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.
test the following differences between Schinder's Target Controlled Infusion (TCI ) model and manually controlled infusion (MCI) :
- remifentanil and propofol total dose given
- incidence of awareness or inadequate anesthesia
- number of rescue dose given
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI | Experimental | Device: Remifentanil and propofol administration using MCImanually controlled infusion will be used |
| TCI | Experimental | Device: Remifentanil and propofol administration using TCITarget Controlled Infusion will be used |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing breast or thyroid surgery
Key exclusion criteria (3 listed)
- BMI > 35
- Surgery shorter than 30 minutes
- Patients with history of: alcol or drug abuse, kidney or liver failure, cardiovascular disease
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 and propofol administration using TCI | Device | TCI |
| Remifentanil and propofol administration using MCI | Device | MCI |
Primary outcome
incidence of awareness or inadequate anesthesia
Time frame: every 3 minutes till the end of surgery
1 secondary outcome
remifentanil and propofol total dose given
Time frame: every 30 minutes till the end of surgery
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 5 Sep 2014.
- Background: PubMed 9640114Russell D. Intravenous anaesthesia: manual infusion schemes versus TCI systems. Anaesthesia. 1998 Apr;53 Suppl 1:42-5. doi: 10.1111/j.1365-2044.1998.53s113.x.
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 study testing Remifentanil and propofol administration using TCI and Remifentanil and propofol administration using MCI in people with Test the Differences Between Schinder's TCI Model and MCI, run by Università degli Studi di Ferrara 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 1 inclusion and 3 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 5 Sep 2014. 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?
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.
What does the primary outcome measure?
incidence of awareness or inadequate anesthesia (time frame: every 3 minutes till the end of surgery). 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 NCT02077478, 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 5 Sep 2014.