AnesthesiaNCT02637726
Bispectral Index Under Propofol Anesthesia in Children : a Study Between TIVA and TCI
A study testing Propofol : TCI Schnider, Propofol : TCI Kataria and Propofol : TIVA in people with Anesthesia, run by Pr Isabelle CONSTANT at 1 site in France.
Trial summary
In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion… Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol : TCI Schnider, Propofol : TCI Kataria and Propofol : TIVA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Mar 2007
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- weighting more than 15 kg;
- American Society of Anesthesiologists physical status I or II
- scheduled for middle ear surgery
Who cannot join
- cardiovascular, neurological, hepatic or renal impairment, if their body mass index was above 95th percentile or if they received any drug interfering with the central nervous system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bispectral Index Under Propofol Anesthesia in Children : a Comparative Randomised Study Between TIVA and TCI
In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS).
Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.
- Conditions
- Anesthesia
- Being tested
- Propofol : TCI Schnider, Propofol : TCI Kataria, Propofol : TIVA, EEG Monitoring, Remifentanil
- Keywords
- Total intravenous anesthesia, Target Controlled Infusion, Propofol, Bispectral index, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol : TCI SchniderDrug
Target controlled infusion using schnider model for propofol
Propofol : TCI KatariaDrug
Target controlled infusion using Kataria model for propofol
Propofol : TIVADrug
Total intravenous anesthesia without use of a pharmokinetic model
EEG MonitoringDevice
Also called BISPECTRAL INDEX
Maintaining a bispectral index between 45 and 55
RemifentanilDrug
Remifentanil at discretion of the anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| TIVA0 | Experimental | Propofol : TIVA guided by clinical signs. Remifentanil Receives: Drug: Propofol : TIVA; Drug: Remifentanil |
| TIVA BIS | Experimental | propofol : TIVA guided by EEG Monitoring. Remifentanil Receives: Drug: Propofol : TIVA; Device: EEG Monitoring; Drug: Remifentanil |
| TCI KBIS | Experimental | Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil. Receives: Drug: Propofol : TCI Kataria; Device: EEG Monitoring; Drug: Remifentanil |
| TCI SBIS | Experimental | Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil. Receives: Drug: Propofol : TCI Schnider; Device: EEG Monitoring; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent at adequate BIS values
Measured: from the beginning to the end of the anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startFeb 2006
- Primary completionMar 2007
- Study completionMar 2007
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr Isabelle CONSTANT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
- Investigators
- Isabelle Constant, PhD, Study director, Hôpital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637726
- Sponsor's protocol ID
- AIVCM
- Status last verified
- Dec 2015
- First submitted
- 16 Dec 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Under Propofol Anesthesia in Children : a Comparative Randomised Study Between TIVA and TCI
- ClinicalTrials.gov ID
- NCT02637726
- Acronym / sponsor ID
- AIVCM
- Conditions
- Anesthesia
- Keywords
- Total intravenous anesthesia, Target Controlled Infusion, Propofol, Bispectral index, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pr Isabelle CONSTANTUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Dec 2015 (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.
In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS).
Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TIVA0 | Experimental | Drug: Propofol : TIVA, Drug: RemifentanilPropofol : TIVA guided by clinical signs. Remifentanil |
| TIVA BIS | Experimental | Drug: Propofol : TIVA, Device: EEG Monitoring, Drug: Remifentanilpropofol : TIVA guided by EEG Monitoring. Remifentanil |
| TCI KBIS | Experimental | Drug: Propofol : TCI Kataria, Device: EEG Monitoring, Drug: RemifentanilPropofol : TCI Kataria guided by EEG Monitoring. Remifentanil. |
| TCI SBIS | Experimental | Drug: Propofol : TCI Schnider, Device: EEG Monitoring, Drug: RemifentanilPropofol : TCI Schnider guided by EEG Monitoring. Remifentanil. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- weighting more than 15 kg;
- American Society of Anesthesiologists physical status I or II
- scheduled for middle ear surgery
Key exclusion criteria (1 listed)
- cardiovascular, neurological, hepatic or renal impairment, if their body mass index was above 95th percentile or if they received any drug interfering with the central nervous system.
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 |
|---|---|---|
| Propofol : TCI SchniderTarget controlled infusion using schnider model for propofol | Drug | TCI SBIS |
| Propofol : TCI KatariaTarget controlled infusion using Kataria model for propofol | Drug | TCI KBIS |
| Propofol : TIVATotal intravenous anesthesia without use of a pharmokinetic model | Drug | TIVA BIS, TIVA0 |
| EEG MonitoringAlso: BISPECTRAL INDEXMaintaining a bispectral index between 45 and 55 | Device | TCI KBIS, TCI SBIS, TIVA BIS |
| RemifentanilRemifentanil at discretion of the anesthesiologist | Drug | TCI KBIS, TCI SBIS, TIVA BIS, TIVA0 |
Primary outcome
Percentage of time spent at adequate BIS values
Time frame: from the beginning to the end of the anesthesia
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 22 Dec 2015.
- 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.
Isabelle Constant, PhD study director
Hôpital Armand Trousseau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol : TCI Schnider, Propofol : TCI Kataria and Propofol : TIVA in people with Anesthesia, run by Pr Isabelle CONSTANT at 1 site in France.
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 1 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 22 Dec 2015. 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 France. 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?
Percentage of time spent at adequate BIS values (time frame: from the beginning to the end of the anesthesia). 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 22 Dec 2015.