Target Controlled InfusionPhase 4(TITINDUC)NCT02999126
Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance
A Phase 4 study testing Propofol and Remifentanil Hydrochloride in people with Target Controlled Infusion and Induction of Anesthesia, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The purpose of this study is to determine if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration required for maintenance of the general anesthesia, with propofol and remifentanil, in adult populations older and younger than 65 years of… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Target Controlled Infusion, Induction of Anesthesia, Bispectral Index
- What is being tested?
- Propofol and Remifentanil Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2016to Mar 2021
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 or 2.
- Age over 20 years old.
- Scheduled to undergo elective surgery of minor or medium complexity under general anesthesia.
- Regarding cognitive function: subjects will be considered with enough cognitive function if they are able to read and understand the medical history form by properly answering medical questions during the preoperative anesthesia assessment and being also able to sign the informed consent form.
Who cannot join
- Pregnancy.
- Obesity (BMI >30).
- Patients taking benzodiazepines or other central nervous system action drugs.
- Subjects with psychiatric disorders with or without treatment.
- Allergies or any adverse reaction to propofol or any of its components (egg lecithin).
Trial locations and contacts
1 site in 1 country.
Hernán Boveri, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
Hernán Boveri, MD, +5491132954777, hernan.boveri@hospitalitaliano.org.ar
About this study
The purpose of this study is to determine if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration required for maintenance of the general anesthesia, with propofol and remifentanil, in adult populations older and younger than 65 years of age.
Read the detailed description
Introduction: Currently, propofol is the most widely used intravenous anesthetic drug that is able to provide a safe general anesthesia. Propofol can be administered by using different techniques including target controlled infusion (TCI). The ability to maintain the pharmacological conditions after achieving a predetermined clinical effect is one of the major advantages of this technique. Although the use of TCI devices has increased in common clinical practice, whether or not all patients are suitable for TCI remains unclear. Pharmacological models were created based on information from healthy volunteers which may not apply for specific clinical conditions resulting either in over- or sub-dosed when using certain drugs.
It is not only individual variability in the pharmacokinetic (PK) parameters of the anesthetic that is a clinical problem, but it is also the pharmacodynamic variability. A previous study showed up to 6 times the inter-individual difference among young volunteers in loss of consciousness (LOC) and return of consciousness (ROC). In addition, greater differences may be found in the elderly.
Inaccurate general models require the anesthetic team to manually tailor medication requirements for each individual based on the desired therapeutic effect.
The purpose of this study is to evaluate if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), assessed by clinical and electroencephalographic parameters, allows for an accurate estimation of the effect concentration required for hypnosis titration and maintenance of the general anesthesia, in adult populations older and younger than 65 years of age.
General Objective
- To establish whether a guided slow stepwise guided propofol induction with TCI represents a good correlation between the calculated Effect-Site Concentration (Ce) for the loss of consciousness and the required Ce to maintain a bispectral index (BIS) value between 45 and 65 during anesthesia maintenance in both age populations
Specific Objectives
- To determine the BIS value achieved with every propofol infusion based on the calculated Ce for the time of loss of consciousness (TLOC)
- To compare the drug infused per time unit required for the loss of consciousness in both groups
- To compare the time and Ce required to achieve loss of consciousness in both groups
- To evaluate the impact of remifentanil during hypnosis by using the BIS index
Hypothesis
During a slow stepwise anesthetic induction with TCI using the Marsh Model 4.0, the calculated Ce for the TLOC is comparable to the Ce required for the maintenance of the hypnosis during the general anesthesia, overcoming the inter-individual variability.
Methods
Experimental study, prospective clinical trial, phase 4. Each subject will be assigned to the propofol induction modality as described in the "intervention" section.
Once consciousness has been lost and maintenance target concentration has been established, manual ventilation will be initiated. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. An infusion of phenylephrine between 0,1 and 0,4 mcg/kg/min will be initiated in order to maintain blood pressure values within 20% of the baseline value.
Continuous monitoring of BIS will be maintained after remifentanil infusion and intubation. Three minutes after endotracheal intubation, surgery will be prepared following standard procedures. BIS, spectrogram, and hemodynamics will be registered every 15 seconds, continuously, and every 3 minutes during 10 minutes respectively.
Subsequently, propofol Ce at TLOC will be established (if any modifications were necessary after TLOC) and it will be observed for another 30 minutes.
- Being tested
- Propofol, Remifentanil Hydrochloride
- Keywords
- Total Intravenous Anesthesia, Titration, Target Controlled Infusion, Propofol, Bispectral index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Fresofol
Propofol intravenously by a stepwise TCI titration with Marsh pharmacokinetic model
Remifentanil HydrochlorideDrug
Remifentanil intravenously 6 ng/ml by TCI effect site, 3 min prior to intubation and maintained at that concentration throughout the study. If clinical signs of inadequate analgesia are present, remifentanil target concentration will be increased by 1 ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients < 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml. Receives: Drug: Propofol; Drug: Remifentanil Hydrochloride |
| Group 2 | Experimental | Patients ≥ 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml. Receives: Drug: Propofol; Drug: Remifentanil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time that BIS range remains within 45 and 65 after a stepwise TCI titration
TCI Effect Site Concentration achieved at LOC, depth of anesthesia will be recorded with BIS bilateral sensor
Measured: A 30-minute period, starting 10 minutes after Remifentanil infusion (when propofol and remifentanil plasma-effect compartment equilibration has been reached)
Secondary outcomes (2)
Time for loss of consciousness
In seconds, using TCI induction with Marsh 4.0 pharmacokinetic model
Measured: Up to First 10 minutes, from start of propofol infusion at time 0 until loss of verbal response
Effect Site Concentration required for loss of consciousness
In mcg/ml, using Marsh Pharmacokinetic Model, Ke0 0.26 min-1
Measured: Up to first 10 minutes. It will be considered the propofol effect site concentration displayed at the moment loss of consciousness is achieved.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Target Controlled InfusionStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hernan Boveri, Hospital Italiano de Buenos Aires
- Investigators
- Hernán Boveri, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999126
- Sponsor's protocol ID
- 2884
- Acronym
- (TITINDUC)
- Status last verified
- Feb 2020
- First submitted
- 8 Dec 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Struys M, Versichelen L, Byttebier G, Mortier E, Moerman A, Rolly G. Clinical usefulness of the bispectral index for titrating propofol target effect-site concentration. Anaesthesia. 1998 Jan;53(1):4-12. doi: 10.1111/j.1365-2044.1998.00279.x.
PubMed 9505735Coppens M, Van Limmen JG, Schnider T, Wyler B, Bonte S, Dewaele F, Struys MM, Vereecke HE. Study of the time course of the clinical effect of propofol compared with the time course of the predicted effect-site concentration: Performance of three pharmacokinetic-dynamic models. Br J Anaesth. 2010 Apr;104(4):452-8. doi: 10.1093/bja/aeq028. Epub 2010 Feb 26.
PubMed 20190259Bienert A, Wiczling P, Grzeskowiak E, Cywinski JB, Kusza K. Potential pitfalls of propofol target controlled infusion delivery related to its pharmacokinetics and pharmacodynamics. Pharmacol Rep. 2012;64(4):782-95. doi: 10.1016/s1734-1140(12)70874-5.
PubMed 23087131Iwakiri H, Nishihara N, Nagata O, Matsukawa T, Ozaki M, Sessler DI. Individual effect-site concentrations of propofol are similar at loss of consciousness and at awakening. Anesth Analg. 2005 Jan;100(1):107-110. doi: 10.1213/01.ANE.0000139358.15909.EA.
PubMed 15616062Struys MM, Sahinovic M, Lichtenbelt BJ, Vereecke HE, Absalom AR. Optimizing intravenous drug administration by applying pharmacokinetic/pharmacodynamic concepts. Br J Anaesth. 2011 Jul;107(1):38-47. doi: 10.1093/bja/aer108. Epub 2011 May 30.
PubMed 21624964Sepulveda PO, Cortinez LI, Recart A, Munoz HR. Predictive ability of propofol effect-site concentrations during fast and slow infusion rates. Acta Anaesthesiol Scand. 2010 Apr;54(4):447-52. doi: 10.1111/j.1399-6576.2009.02183.x. Epub 2009 Dec 14.
PubMed 20003124
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance
- ClinicalTrials.gov ID
- NCT02999126
- Acronym / sponsor ID
- (TITINDUC) / 2884
- Keywords
- Total Intravenous Anesthesia, Titration, Target Controlled Infusion, Propofol, Bispectral index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 Dec 2016 (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.
The purpose of this study is to determine if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration required for maintenance of the general anesthesia, with propofol and remifentanil, in adult populations older and younger than 65 years of age.
Detailed description
Introduction: Currently, propofol is the most widely used intravenous anesthetic drug that is able to provide a safe general anesthesia. Propofol can be administered by using different techniques including target controlled infusion (TCI). The ability to maintain the pharmacological conditions after achieving a predetermined clinical effect is one of the major advantages of this technique. Although the use of TCI devices has increased in common clinical practice, whether or not all patients are suitable for TCI remains unclear. Pharmacological models were created based on information from healthy volunteers which may not apply for specific clinical conditions resulting either in over- or sub-dosed when using certain drugs.
It is not only individual variability in the pharmacokinetic (PK) parameters of the anesthetic that is a clinical problem, but it is also the pharmacodynamic variability. A previous study showed up to 6 times the inter-individual difference among young volunteers in loss of consciousness (LOC) and return of consciousness (ROC). In addition, greater differences may be found in the elderly.
Inaccurate general models require the anesthetic team to manually tailor medication requirements for each individual based on the desired therapeutic effect.
The purpose of this study is to evaluate if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), assessed by clinical and electroencephalographic parameters, allows for an accurate estimation of the effect concentration required for hypnosis titration and maintenance of the general anesthesia, in adult populations older and younger than 65 years of age.
General Objective
- To establish whether a guided slow stepwise guided propofol induction with TCI represents a good correlation between the calculated Effect-Site Concentration (Ce) for the loss of consciousness and the required Ce to maintain a bispectral index (BIS) value between 45 and 65 during anesthesia maintenance in both age populations
Specific Objectives
- To determine the BIS value achieved with every propofol infusion based on the calculated Ce for the time of loss of consciousness (TLOC)
- To compare the drug infused per time unit required for the loss of consciousness in both groups
- To compare the time and Ce required to achieve loss of consciousness in both groups
- To evaluate the impact of remifentanil during hypnosis by using the BIS index
Hypothesis
During a slow stepwise anesthetic induction with TCI using the Marsh Model 4.0, the calculated Ce for the TLOC is comparable to the Ce required for the maintenance of the hypnosis during the general anesthesia, overcoming the inter-individual variability.
Methods
Experimental study, prospective clinical trial, phase 4. Each subject will be assigned to the propofol induction modality as described in the "intervention" section.
Once consciousness has been lost and maintenance target concentration has been established, manual ventilation will be initiated. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. An infusion of phenylephrine between 0,1 and 0,4 mcg/kg/min will be initiated in order to maintain blood pressure values within 20% of the baseline value.
Continuous monitoring of BIS will be maintained after remifentanil infusion and intubation. Three minutes after endotracheal intubation, surgery will be prepared following standard procedures. BIS, spectrogram, and hemodynamics will be registered every 15 seconds, continuously, and every 3 minutes during 10 minutes respectively.
Subsequently, propofol Ce at TLOC will be established (if any modifications were necessary after TLOC) and it will be observed for another 30 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Propofol, Drug: Remifentanil HydrochloridePatients < 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml. |
| Group 2 | Experimental | Drug: Propofol, Drug: Remifentanil HydrochloridePatients ≥ 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1 or 2.
- Age over 20 years old.
- Scheduled to undergo elective surgery of minor or medium complexity under general anesthesia.
- Regarding cognitive function: subjects will be considered with enough cognitive function if they are able to read and understand the medical history form by properly answering medical questions during the preoperative anesthesia assessment and being also able to sign the informed consent form.
Key exclusion criteria (5 listed)
- Pregnancy.
- Obesity (BMI >30).
- Patients taking benzodiazepines or other central nervous system action drugs.
- Subjects with psychiatric disorders with or without treatment.
- Allergies or any adverse reaction to propofol or any of its components (egg lecithin).
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 |
|---|---|---|
| PropofolAlso: FresofolPropofol intravenously by a stepwise TCI titration with Marsh pharmacokinetic model | Drug | Group 1, Group 2 |
| Remifentanil HydrochlorideRemifentanil intravenously 6 ng/ml by TCI effect site, 3 min prior to intubation and maintained at that concentration throughout the study. If clinical signs of inadequate analgesia are present, remifentanil target concentration will be increased by 1 ng/ml. | Drug | Group 1, Group 2 |
Primary outcome
Time that BIS range remains within 45 and 65 after a stepwise TCI titration
Time frame: A 30-minute period, starting 10 minutes after Remifentanil infusion (when propofol and remifentanil plasma-effect compartment equilibration has been reached)
TCI Effect Site Concentration achieved at LOC, depth of anesthesia will be recorded with BIS bilateral sensor
2 secondary outcomes
Time for loss of consciousness
Time frame: Up to First 10 minutes, from start of propofol infusion at time 0 until loss of verbal response
Effect Site Concentration required for loss of consciousness
Time frame: Up to first 10 minutes. It will be considered the propofol effect site concentration displayed at the moment loss of consciousness is achieved.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 9505735Struys M, Versichelen L, Byttebier G, Mortier E, Moerman A, Rolly G. Clinical usefulness of the bispectral index for titrating propofol target effect-site concentration. Anaesthesia. 1998 Jan;53(1):4-12. doi: 10.1111/j.1365-2044.1998.00279.x.
- Background: PubMed 20190259Coppens M, Van Limmen JG, Schnider T, Wyler B, Bonte S, Dewaele F, Struys MM, Vereecke HE. Study of the time course of the clinical effect of propofol compared with the time course of the predicted effect-site concentration: Performance of three pharmacokinetic-dynamic models. Br J Anaesth. 2010 Apr;104(4):452-8. doi: 10.1093/bja/aeq028. Epub 2010 Feb 26.
- Background: PubMed 23087131Bienert A, Wiczling P, Grzeskowiak E, Cywinski JB, Kusza K. Potential pitfalls of propofol target controlled infusion delivery related to its pharmacokinetics and pharmacodynamics. Pharmacol Rep. 2012;64(4):782-95. doi: 10.1016/s1734-1140(12)70874-5.
- Background: PubMed 15616062Iwakiri H, Nishihara N, Nagata O, Matsukawa T, Ozaki M, Sessler DI. Individual effect-site concentrations of propofol are similar at loss of consciousness and at awakening. Anesth Analg. 2005 Jan;100(1):107-110. doi: 10.1213/01.ANE.0000139358.15909.EA.
- Background: PubMed 21624964Struys MM, Sahinovic M, Lichtenbelt BJ, Vereecke HE, Absalom AR. Optimizing intravenous drug administration by applying pharmacokinetic/pharmacodynamic concepts. Br J Anaesth. 2011 Jul;107(1):38-47. doi: 10.1093/bja/aer108. Epub 2011 May 30.
- Background: PubMed 20003124Sepulveda PO, Cortinez LI, Recart A, Munoz HR. Predictive ability of propofol effect-site concentrations during fast and slow infusion rates. Acta Anaesthesiol Scand. 2010 Apr;54(4):447-52. doi: 10.1111/j.1399-6576.2009.02183.x. Epub 2009 Dec 14.
- 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.
Hernán Boveri, MD contact
Hernán Boveri, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Remifentanil Hydrochloride in people with Target Controlled Infusion and Induction of Anesthesia, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. 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 Argentina. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hernán Boveri, MD (hernan.boveri@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time that BIS range remains within 45 and 65 after a stepwise TCI titration (time frame: A 30-minute period, starting 10 minutes after Remifentanil infusion (when propofol and remifentanil plasma-effect compartment equilibration has been reached)). 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 NCT02999126, which also lists 6 linked publications.
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 18 Feb 2020; AzTrials last refreshed its copy on 31 Oct 2026.