Awareness, AnesthesiaTCINCT04129112
Evaluation of Influencing Variables in Awakening Concentration and Concentration at Body Movements of Propofol TCI (Targeted Controlled Infusion) Targeted at the Effector Site
An observational study of Awareness, Anesthesia, run by University of Padova at 1 site in Italy.
Trial summary
Age has been related to awakening propofol concentration at effector site of TCI, but not to the loss of consciousness concentration, neither to the concentration of body movements during surgery, that can be interpreted as a sign of light anesthesia and lead to awareness. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Awareness, Anesthesia
- What is being tested?
- We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2025to 15 Dec 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: we recruited adult (> 18 years old) undergoing general surgery in Treviso Regional Hospital. We excluded patients with any neurological or psychiatric or cerebrovascular diseases and renal insufficiency in anamnesis, who were unable to understand the information contained in the informed consent form, and patients with intraoperative hemodynamic instability or who was delivered curare agents during anaesthesia.
Who may be able to join
- Patients undergoing general anesthesia with propofol and remifentanil delivered with TCI infusion pump
Who cannot join
- neurological or psychiatric or cerebrovascular diseases
- renal insufficiency
- patients unable to understand the information contained in the informed consent form,
- patients with intraoperative hemodynamic instability or
- patients who was delivered curare agents during anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Age has been related to awakening propofol concentration at effector site of TCI, but not to the loss of consciousness concentration, neither to the concentration of body movements during surgery, that can be interpreted as a sign of light anesthesia and lead to awareness.
This study aims to determinate the incidence and the propofol TCI concentration at the effector site, in patients undergoing general anaesthesia without NBDs, of any patients body movements, defined as any spontaneous movements (but no reflex movements) during surgery.
Read the detailed description
Target-Controlled-Infusion (TCI), estimating the effect-size concentration (Ce) of propofol and its elimination time with a computerized system, provides the anaesthesiologist useful information to guide anaesthesia.
Although the correlation between propofol at the effector site at loss of consciousness (Ce LOC) and age is still debated with contrasting results, the correlation between propofol at the effector site at return of consciousness (Ce ROC) and age is well established, and some authors suggested that, due also for age-related changes in both pharmacokinetics and pharmacodynamics of propofol, its dosage should be reduced in elderly patients.
Lowering propofol dosage however, can lead to an higher incidence of awareness during general anaesthesia, even if anaesthesia management is guided by consciousness monitors.
Awareness during anaesthesia has recently been defined not as a binary phenomenon, but as a graded spectra of states and, during general anaesthesia without using neuromuscular blocking drugs (NBDs), body movement on the operating table can be taken as an indication of increasing probability of consciousness or 'light' anaesthesia.
Hence, this study aims to evaluate the impact of age on the concentration at the effector site of propofol-remifentanil anaesthesia administered with TCI pump and without NBDs. Concnetration at the effector site of Propofol at the return of consciousness (CeP ROC) and at any clinical sign of superficialization such as body movements (CeP BM) will be considered.
- Conditions
- Awareness, Anesthesia
- Being tested
- We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakeningDrug
Propofol in our hospital is routinely delivered by Targeted Controlled Infusion (TCI) pumps. We note the concentration of propofol at the effector site of body movements and awakening
| Study group | Role | What they receive |
|---|---|---|
| Patients without body movements | Patient who, under general anesthesia without curare agents, during surgery has no body movements Receives: Drug: We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening | |
| Patients with body movements | Patient who, under general anesthesia without curare agents, during surgery has any body movements that are no reflexes movements Receives: Drug: We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of body movements in patients undergoing surgery without curare agents
We will note if patients have spontaneous movements during surgery, and calculate the incidence of the phenomenon.
Measured: During surgery
Secondary outcomes (2)
Concentration of propofol at body movements
We will note the concentration at the effector site of propofol TCI during body movements and compare them to pre-operative and demographical variables (age, weight, height, American Society of Anaesthesiologist physical status classification system (ASA), number of previous general anaesthesia, years of schooling, Sort Portable Mental Status Questionnaire score) and intra-operative variables ( concentration at the effector site of remifentanil at ventilator maladjustment (CeR VM), mean Ce propofol and remifentanil target during maintenance, and maximum, mean and minimum State Entropy (SE) and Response Entropy (RE) or Bispectral Index (BIS) and Surgical Pleth Index (SPI) values during maintenance).
Measured: Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery
Concentration of propofol at return of consciousness
We will note the concentration at the effector site of propofol TCI at awakening and compare them to pre-operative and demographical variables (age, weight, height, American Society of Anaesthesiologist physical status classification system (ASA), number of previous general anaesthesia, years of schooling, Sort Portable Mental Status Questionnaire score) and intra-operative variables ( concentration at the effector site of remifentanil at ventilator maladjustement (CeR VM), mean Ce propofol and remifentanil target during maintenance, and maximum, mean and minimum SE and RE Entropy values during maintenance).
Measured: Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start8 Jan 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awareness, 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 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
- NCT04129112
- Sponsor's protocol ID
- CorMA
- Acronym
- TCI
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Influencing Variables in Awakening Concentration and Concentration at Body Movements of Propofol TCI (Targeted Controlled Infusion) Targeted at the Effector Site
- ClinicalTrials.gov ID
- NCT04129112
- Acronym / sponsor ID
- TCI / CorMA
- Conditions
- Awareness, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 16 Oct 2019 (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.
Age has been related to awakening propofol concentration at effector site of TCI, but not to the loss of consciousness concentration, neither to the concentration of body movements during surgery, that can be interpreted as a sign of light anesthesia and lead to awareness.
This study aims to determinate the incidence and the propofol TCI concentration at the effector site, in patients undergoing general anaesthesia without NBDs, of any patients body movements, defined as any spontaneous movements (but no reflex movements) during surgery.
Detailed description
Target-Controlled-Infusion (TCI), estimating the effect-size concentration (Ce) of propofol and its elimination time with a computerized system, provides the anaesthesiologist useful information to guide anaesthesia.
Although the correlation between propofol at the effector site at loss of consciousness (Ce LOC) and age is still debated with contrasting results, the correlation between propofol at the effector site at return of consciousness (Ce ROC) and age is well established, and some authors suggested that, due also for age-related changes in both pharmacokinetics and pharmacodynamics of propofol, its dosage should be reduced in elderly patients.
Lowering propofol dosage however, can lead to an higher incidence of awareness during general anaesthesia, even if anaesthesia management is guided by consciousness monitors.
Awareness during anaesthesia has recently been defined not as a binary phenomenon, but as a graded spectra of states and, during general anaesthesia without using neuromuscular blocking drugs (NBDs), body movement on the operating table can be taken as an indication of increasing probability of consciousness or 'light' anaesthesia.
Hence, this study aims to evaluate the impact of age on the concentration at the effector site of propofol-remifentanil anaesthesia administered with TCI pump and without NBDs. Concnetration at the effector site of Propofol at the return of consciousness (CeP ROC) and at any clinical sign of superficialization such as body movements (CeP BM) will be considered.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without body movements | – | Drug: We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakeningPatient who, under general anesthesia without curare agents, during surgery has no body movements |
| Patients with body movements | – | Drug: We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakeningPatient who, under general anesthesia without curare agents, during surgery has any body movements that are no reflexes movements |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- we recruited adult (> 18 years old) undergoing general surgery in Treviso Regional Hospital. We excluded patients with any neurological or psychiatric or cerebrovascular diseases and renal insufficiency in anamnesis, who were unable to understand the information contained in the informed consent form, and patients with intraoperative hemodynamic instability or who was delivered curare agents during anaesthesia.
Key inclusion criteria (1 listed)
- Patients undergoing general anesthesia with propofol and remifentanil delivered with TCI infusion pump
Key exclusion criteria (5 listed)
- neurological or psychiatric or cerebrovascular diseases
- renal insufficiency
- patients unable to understand the information contained in the informed consent form,
- patients with intraoperative hemodynamic instability or
- patients who was delivered curare agents during anaesthesia
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 |
|---|---|---|
| We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakeningPropofol in our hospital is routinely delivered by Targeted Controlled Infusion (TCI) pumps. We note the concentration of propofol at the effector site of body movements and awakening | Drug | Patients with body movements, Patients without body movements |
Primary outcome
Incidence of body movements in patients undergoing surgery without curare agents
Time frame: During surgery
We will note if patients have spontaneous movements during surgery, and calculate the incidence of the phenomenon.
2 secondary outcomes
Concentration of propofol at body movements
Time frame: Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery
Concentration of propofol at return of consciousness
Time frame: Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during 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 7 Oct 2026.
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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.
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 Awareness, Anesthesia, run by University of Padova 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 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 7 Oct 2026. 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 body movements in patients undergoing surgery without curare agents (time frame: During 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 7 Oct 2026.