PropofolTCINCT06098196
Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness
An observational study of Propofol and Anesthesia Brain Monitoring, run by University of Padova at 2 sites in Italy.
Trial summary
Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Propofol, Anesthesia Brain Monitoring
- What is being tested?
- Aminophyllin
- How many people
- 48 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Oct 2023to 15 Mar 2024
- Phase
- Observational
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, with or without aminophylline bolus at the end of surgery will be recruited
Who may be able to join
- Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)
Who cannot join
- Neurological disease
- Psychiatric disease
- Obesity
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
ULSS 2 Marca Trevigiana
Treviso, Tv, 31100
ULSS2 Marca Trevigiana
Treviso, 31100
About this study
Official title: Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness and on BIS (Bispectral Index) After Total Intravenous Anaesthesia With TCI
Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.
We aimed to compare its effect during a total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.
Read the detailed description
Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.
We aimed to compare its effect during a total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital (with Eleveld or Schnider Pharmacokinetic/Pharmacodynamic-PK/PD model).
The timing from stop of propofol infusion to eye opening and return of responsiveness, the relative Concentration of Propofol (CeP) and the power spectrum of the Bispectral Index (BIS) with or without aminophylline bolus were taken into account.
- Conditions
- Propofol, Anesthesia Brain Monitoring
- Being tested
- Aminophyllin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminophyllinDrug
Patients will be observationally included in the Elveld TCI or Schnider TCI group and recevied or not Aminiophylline bolus. The TCI model, such as the aminophylline delivery or not, is chosen at anesthesiologist's discretion, as suggested in literature
| Study group | Role | What they receive |
|---|---|---|
| Aminophylline | Patients who received Aminophylline bolus (4 mg/kg) at the end of general anesthesia conducted with Eleveld or Schnider TCI model (this model was chosen at anesthesiologist's discretion) Receives: Drug: Aminophyllin | |
| Not Aminophylline | Patients who did not received Aminophylline bolus (4 mg/kg) at the end of general anesthesia conducted with Eleveld or SchniderTCI model (this model was chosen at anesthesiologist's discretion Receives: Drug: Aminophyllin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Concentration at the effector site of Propofol after Aminophylline
Discover if, after an aminophylline bolus, there are differences between Concentrations at the effector site and timing at eye opening of Propofol using the Eleveld TCI model or Schnider TCI model, after standard general anaesthesia conducted with Propofol and remifentanil delivered with target controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia
Measured: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of anaesthesia until the emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start25 Oct 2023
- Primary completion28 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Linassi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098196
- Sponsor's protocol ID
- Teoawake
- Acronym
- TCI
- Status last verified
- Apr 2024
- First submitted
- 18 Oct 2023
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness and on BIS (Bispectral Index) After Total Intravenous Anaesthesia With TCI
- ClinicalTrials.gov ID
- NCT06098196
- Acronym / sponsor ID
- TCI / Teoawake
- Conditions
- Propofol, Anesthesia Brain Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 24 Oct 2023 (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.
Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.
We aimed to compare its effect during a total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.
Detailed description
Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.
We aimed to compare its effect during a total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital (with Eleveld or Schnider Pharmacokinetic/Pharmacodynamic-PK/PD model).
The timing from stop of propofol infusion to eye opening and return of responsiveness, the relative Concentration of Propofol (CeP) and the power spectrum of the Bispectral Index (BIS) with or without aminophylline bolus were taken into account.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminophylline | – | Drug: AminophyllinPatients who received Aminophylline bolus (4 mg/kg) at the end of general anesthesia conducted with Eleveld or Schnider TCI model (this model was chosen at anesthesiologist's discretion) |
| Not Aminophylline | – | Drug: AminophyllinPatients who did not received Aminophylline bolus (4 mg/kg) at the end of general anesthesia conducted with Eleveld or SchniderTCI model (this model was chosen at anesthesiologist's discretion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, with or without aminophylline bolus at the end of surgery will be recruited
Key inclusion criteria (1 listed)
- Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)
Key exclusion criteria (3 listed)
- Neurological disease
- Psychiatric disease
- Obesity
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 |
|---|---|---|
| AminophyllinPatients will be observationally included in the Elveld TCI or Schnider TCI group and recevied or not Aminiophylline bolus. The TCI model, such as the aminophylline delivery or not, is chosen at anesthesiologist's discretion, as suggested in literature | Drug | Aminophylline, Not Aminophylline |
Primary outcome
Correlation between Concentration at the effector site of Propofol after Aminophylline
Time frame: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of anaesthesia until the emergence from anesthesia
Discover if, after an aminophylline bolus, there are differences between Concentrations at the effector site and timing at eye opening of Propofol using the Eleveld TCI model or Schnider TCI model, after standard general anaesthesia conducted with Propofol and remifentanil delivered with target controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia
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 25 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Propofol and Anesthesia Brain Monitoring, run by University of Padova at 2 sites 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Correlation between Concentration at the effector site of Propofol after Aminophylline (time frame: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of anaesthesia until the emergence from 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 25 Apr 2024.