Hemodynamic InstabilityNCT03961958
Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning
A study testing Propofol reduction in people with Hemodynamic Instability and Anesthesia, run by University of Salamanca at 1 site in Portugal.
Trial summary
Induction of anesthesia and the knee-chest position are associated with hemodynamic changes that may impact patient outcomes. Changes from baseline in cardiac output and other hemodynamic variables following induction of anesthesia and knee-chest positioning were compared. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability, Anesthesia, Surgery
- What is being tested?
- Propofol reduction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2009to Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lumbar spinal condition for surgical treatment in knee-chest position
Who cannot join
- Severe ischemic heart disease
- Congestive heart failure
- Atrial fibrillation or flutter
- Body mass index > 35 kg/m2
- Glasgow Coma Scale < 15
- Dementia disease
Show all 9Show fewer
- History of drug abuse or addiction
- Consumption of opioid medication
- Pre-operative administration of midazolam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia
Induction of anesthesia and the knee-chest position are associated with hemodynamic changes that may impact patient outcomes.
Changes from baseline in cardiac output and other hemodynamic variables following induction of anesthesia and knee-chest positioning were compared. Propofol plasma concentrations were also measured after induction of anesthesia and after the knee-chest position.
Read more
The aim of this study was to assess whether planned reductions in target-controlled infusion propofol concentrations attenuate the hemodynamic changes associated with anesthesia induction and knee-chest position.
The secondary aim was to quantify the variation in propofol measured plasma concentrations (Cm), both after induction and after KC positioning, and correlate them with predicted concentrations (Cp) by the Schnider Pk model.
Read the detailed description
A total of 20 patients scheduled for elective lumbar spinal surgery in the knee-chest position were included. In addition to standard anesthesia monitoring, bispectral index and noninvasive cardiac output monitoring were undertaken. The study was carried out in 2 parts. In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness: reduction calculated using a predefined formula, and (2) before positioning: reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.
- Conditions
- Hemodynamic Instability, Anesthesia, Surgery
- Being tested
- Propofol reduction
- Keywords
- Hemodynamics, Knee-Chest Position, Propofol, Anesthesia, General, Anesthetics, Intravenous, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol reductionDrug
Reduction of propofol target concentration
| Study group | Role | What they receive |
|---|---|---|
| No protocolled propofol reduction | No intervention | In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. |
| Two protocolled propofol reductions | Experimental | In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness-reduction calculated using a predefined formula, and (2) before positioning-reduction equal to the average percentage decrease in CO after knee-chest position in phase Receives: Drug: Propofol reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic changes
Changes from baseline in cardiac output and comparison of the changes between both groups.
Measured: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
Secondary outcomes (1)
Pharmacokinetic changes
Correlation between propofol measured plasma concentrations and predicted plasma concentrations (Cp) by the Schnider Pk model.
Measured: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study startJul 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness - reduction calculated using a predefined formula, and (2) before positioning - reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar do Porto
- Responsible party
- Principal investigator, Daniela Chalo, University of Salamanca
- Investigators
- Consuelo S Sanchez, PhD, Study director, University of Salamanca, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961958
- Sponsor's protocol ID
- USalamanca
- Status last verified
- May 2019
- First submitted
- 11 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia
- ClinicalTrials.gov ID
- NCT03961958
- Acronym / sponsor ID
- USalamanca
- Conditions
- Hemodynamic Instability, Anesthesia, Surgery
- Keywords
- Hemodynamics, Knee-Chest Position, Propofol, Anesthesia, General, Anesthetics, Intravenous, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Centro Hospitalar do Porto
- Study start
- Jul 2009 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 May 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.
Induction of anesthesia and the knee-chest position are associated with hemodynamic changes that may impact patient outcomes.
Changes from baseline in cardiac output and other hemodynamic variables following induction of anesthesia and knee-chest positioning were compared. Propofol plasma concentrations were also measured after induction of anesthesia and after the knee-chest position.
The aim of this study was to assess whether planned reductions in target-controlled infusion propofol concentrations attenuate the hemodynamic changes associated with anesthesia induction and knee-chest position.
The secondary aim was to quantify the variation in propofol measured plasma concentrations (Cm), both after induction and after KC positioning, and correlate them with predicted concentrations (Cp) by the Schnider Pk model.
Detailed description
A total of 20 patients scheduled for elective lumbar spinal surgery in the knee-chest position were included. In addition to standard anesthesia monitoring, bispectral index and noninvasive cardiac output monitoring were undertaken. The study was carried out in 2 parts. In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness: reduction calculated using a predefined formula, and (2) before positioning: reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness - reduction calculated using a predefined formula, and (2) before positioning - reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.
| Arm | Type | Receives |
|---|---|---|
| No protocolled propofol reduction | No intervention | –In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. |
| Two protocolled propofol reductions | Experimental | Drug: Propofol reductionIn phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness-reduction calculated using a predefined formula, and (2) before positioning-reduction equal to the average percentage decrease in CO after knee-chest position in phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lumbar spinal condition for surgical treatment in knee-chest position
Key exclusion criteria (9 listed)
- Severe ischemic heart disease
- Congestive heart failure
- Atrial fibrillation or flutter
- Body mass index > 35 kg/m2
- Glasgow Coma Scale < 15
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 reductionReduction of propofol target concentration | Drug | Two protocolled propofol reductions |
Primary outcome
Hemodynamic changes
Time frame: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
Changes from baseline in cardiac output and comparison of the changes between both groups.
1 secondary outcome
Pharmacokinetic changes
Time frame: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
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 23 May 2019.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication will be shared
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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.
Consuelo S Sanchez, PhD study director
University of Salamanca, Faculty of Medicine
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 reduction in people with Hemodynamic Instability and Anesthesia, run by University of Salamanca at 1 site in Portugal.
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 9 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 23 May 2019. 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 Portugal. 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?
Hemodynamic changes (time frame: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)). 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 23 May 2019.