Aging ProblemsBaseDexmedNCT05425069
Evaluation of the EEG Connectivity Using Predominant Dexmedetomidine as Anesthetic in Fragile Brains
An observational study of Aging Problems, run by Universidad del Desarrollo at 1 site in Chile.
Trial summary
Elderly brains that present a lower intrinsic cortical activity are very dependent on arousal feeding. In these patients, a strong blockade of afferences generates a synchronic state with a high tendency to sleep. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Problems
- What is being tested?
- Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteChile
- Study dates
- 2 Jan 2022to 30 Jun 2022
- How long will I take part?
- 10 Months
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients over 70 years, programmed to elective surgery longer than 60 min
Who may be able to join
- Eligibility criteria Inclusion criteria
- surgery over 60 min
- ASA I - II
- Age: over 70 years old
Who cannot join
- - Neurological, or systemic disease that affects the central nervous system in a secondary way
- Abnormal admission neurological physical exam
- Consumption of benzodiazepines, tricyclic antidepressants, sympathomimetics, modafinil, opioid analgesics, histaminergic, antihistamines, cholinergic, anticholinergics, dopaminergic, antidopaminergic, and antihypertensive with alpha-agonist effect in the last 48 hours.
- History of adverse or allergic reactions to Propofol (allergy to soy or any other component of it)
- History of alcohol or drug abuse
- Subjects with "fast sequence induction" indication
Show all 9Show fewer
- Withdrawal criteria:
- Patients presenting with any adverse event during induction (excitation, hypotension, bradycardia <40 x min, nausea).
- Subsequent refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Base San Jose
Osorno, Los Lagos Region
Pablo O Sepulveda, DrMed, 56994793336, pasevou@gmail.com
David Obert, DrMed
About this study
Official title: Evaluation of the EEG Connectivity Using Predominantly Dexmedetomidine Anesthesia Versus Traditional TCI Propofol in Fragile Brains
Elderly brains that present a lower intrinsic cortical activity are very dependent on arousal feeding. In these patients, a strong blockade of afferences generates a synchronic state with a high tendency to sleep. This is done with drugs such as Dexmedetomidine and its indirect effect of inhibiting the amplification of signals and opioids such as remifentanil. Then, by adding a micro-dose of a gabaergic substance to induce loss of consciousness, unconsciousness would be maintained due to the low requirement of a fragile and synchronous brain by a slow continuous injection of an alpha2 agonist. In previous experience, doses of about one-fifth of the usual would be sufficient to maintain unconsciousness (or perhaps disconnected consciousness that could be useful in avoiding excessive depression in slowed integration pathways). These patients also present deficits in the orexinergic response that manifest themselves in greater neuronal inertia and delayed awakening. Gabaergic drugs (propofol and sevoflurane) are especially depressing to orexinergic nuclei.
This approach to the elderly brain could have an impact on recovering more easily connectivity of those CNC networks.
In elderly patients, one aspect that could control the phenomena of altered connectivity and its impact in developing delirium is the limitation of connection with the environment before the capacity of integration of cortical information has been completely recovered. To analyze frontoparietal connectivity, front frontal coherence, phase lag index, or similar it is necessary to a multichannel EEG (e.g. 10 channels). Otherwise, the frontal EEG from the SEDline monitor device allowed to analyze only spectral characteristics (power, peak frequency, etc.) and correlate them with clinical observations (MoCA).
Read the detailed description
Research question: Does subcortical drug-based anesthesia allow better recovery of consciousness (integration of information) than the classic gabaergic drug-based technique in elderly and fragile brains?
Primary hypothesis: The anesthetic technique based on subcortical anesthesia with Dexmedetomidine and Remifentanil and minimal gabaergic doses (Propofol) allow fragile and slower brains a faster recovery of cortical connectivity. This behavior represents part of the evidence of neural inertia in sleep and anesthesia.
Objectives:
- Primary: Evaluation of the normalization of the frontal EEG of patients with mostly subcortical anesthesia (Dexmedetomidine-Remifentanil.-low Propofol in TCI ) or classic technique (Remifentanil-Propofol in TCI) versus its preoperative basal control.
- Secondary:
- To estimate the recovery of the cognitive condition with MoCA test, agitation scale, and delirium CAM-ICU.
- To identify behavioral patterns of the EEG with two different anesthetic techniques
Participants
- Target population: Patients scheduled for elective surgery, any sex, non-neurological procedure lasting more than 60 minutes, who do not meet the exclusion criteria.
- Eligibility criteria Inclusion criteria: - ASA I - II - Age: over 70 years old
Exclusion criteria:
- Neurological, or systemic disease that affects the central nervous system in a secondary way
- Abnormal admission neurological physical exam
- Consumption of benzodiazepines, tricyclic antidepressants, sympathomimetics, modafinil, opioid analgesics, histaminergic, antihistamines, cholinergic, anticholinergics, dopaminergic, antidopaminergic, and antihypertensive with alpha-agonist effect in the last 48 hours.
- History of adverse or allergic reactions to Propofol (allergy to soy or any other component of it)
- History of alcohol or drug abuse
- Subjects with "fast sequence induction" indication
Withdrawal criteria:
- Patients presenting with any adverse event during induction (excitation, hypotension, bradycardia <40 x min, nausea).
- Subsequent refusal to participate in the study
- Randomize patients into two groups of a similar number of individuals. Group 1: Propofol TCI - Remifentanil anesthesia. TCI Propofol (Schnider PKPD model), 5-minute step-by-step induction. After LOC stay in this calculated effect site concentration, add Remifentanil TCI PKPD model Minto target 4.5 ng/ml, Rocuronium intubation dose. EEG Sedline monitoring all the surgery until 1 hour postoperatively Group 2: Dexmedetomidine 0.8 ug/kg/h during 10 minutes- then Propofol TCI target 2 ug/ml (Schnidel model) during 3 min and reduce to 0.5 ug/ml, Remifentanil TCI (PK model Minto), after LOC Rocuronium intubation dose. EEG Sedline monitoring all the surgery until 1 hour postoperatively 0,5 ug/ml after LOC
- Both groups were evaluated with MoCA and CAMICU tests: Pre-operative and post-operative cognitive assessments will be performed with MoCA test and CAMICU test, which will be correlated with the EEG characteristics of each group both in the baseline measurements, intraoperative behavior, and after one hour in the recovery room
- Basal frontal EEG with eyes opened and closed (90 sec each) preoperatively without any drug effect
To protect the risk of awareness or excess of EEG depression, during surgery, Anesthesia will be dynamically adjusted to maintain SEF95 remains at minimum values at 8-10 Hz for the rest of the surgery.
Sedline will be maintained for up to 60 min post-op. in the recovery room. Data will be retrieved via pen drive stick (edf data corresponding to raw EEG) and other trends data of the Sedlie monitor using the proprietary software Masimo Instrument Configuration Tools
In both groups, the Systolic Blood Pressure, Freq. Cardiac, Pulse Oximetry, Capnography, and Sedline EEG will be monitored throughout the surgical procedure and for at least one hour postoperatively. No drugs such as ketamine, midazolam, atropine, or other anticholinergics will be used at any time.
Hemodynamics will be supported with volume, ephedrine, or phenylephrine according to the criteria of the anesthesiologist.
Unexpected events during the induction: Any anesthetic induction has risks of hemodynamic instability, arrhythmias, and respiratory apneas. Most of them are easy to handle anesthesiological based on volume, vasoactive drugs such as ephedrine, and respiratory assistance.
In this case, a minimum or no incidence of these is expected because healthy patients are included.
Exceptional situations such as anaphylactic reactions to propofol (very rarely described) will be cause for suspension of the case study and treated with usual protocols for the case.
During the Surgery, the analgesic requirement will be adjusted with Remifentanil TCI concentration in the clinical criterium of the anesthetist.
Postoperative analgesia will be multimodal, with or without regional block depending on the anesthetist's criterium and type of surgery.
Database and data management: SEDLINE data is retrieved online by proprietary software to a PC. These, together with the manual control data, will be collected in a Microsoft Excel 2011 worksheet and exported to a STATA 10 statistical program template, with which the analysis will be performed.
A work together with the Basic Data Manager of the Anesthesia Service to safeguard the information and its confidentiality.
- Conditions
- Aging Problems
- Being tested
- Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P
- Keywords
- Frailty brain, Dexmedetomidine, Propofol, MoCA test, Frontal EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-PDrug
Also called comparison EEG evolution between study groups
We compare de impact in EEG, anesthetic condition, and recovery EEG and cognitive clinical characteristic with MoCA test between both groups (propofol vs propofol dexmedetomidine)
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine with minimal concentration of propofol (D-P) | Intravenous infusion with Dexmedetomidine for 10 minutes at 0.8 ug/kg/hr and so on, then induction with Propofol TCI Target 2.0 ug/ml (Schnider model) and Remifentanil TCI 4.5 ng/ml. 3 minutes after LOC Propofol will be reduced to 0.5 ug/ml. intubate using Remifentanil 4.5 ng/ml and Rocuronio 0.5 mg/kg.
Anesthesia will be dynamically adjusted to maintain SEF95 remains at minimum values at 10 Hz for the rest of the surgery. Sedline will be maintained for up to 60 min post-op. in the recovery room. Data will be retrieved via pen drive stick from SEdline Receives: Drug: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P | |
| Propofol TCI fine titrated (P) | Basal frontal EEG with eyes opened and closed (90 sec each) The previous bolus of Lidocaine in a 20 mg intravenous dose, TCI Propofol Induction (Schnider Model) is initiated starting 8 mg/kg/h until clinical unconsciousness (LOC loss of response to the call and to moderate stimulus in the shoulder) and then it is passed to TCI to keep the Ce calculated to the LOC.
After LOC, we proceed to intubate using Remifentanil 4.5 ng/ml and Rocuronio. Anesthesia will be dynamically adjusted to maintain Sedline SEF 95 value of minimum at 10Hz. Sedline will be maintained for up to 60 min post LOC in the recovery room.
Data will be retrieved via pen drive stick. Receives: Drug: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of both groups in Recovery Cognitive and electroencephalogram EEG Conditions, during and after surgery
Measuring instruments: Cognitive MoCA test (Montreal Cognitive assessment) pre and one-hour post-operative.
Drug consumption to maintain a Spectral Edge Frequency SEF 95 over 10Hz as calculated Propofol effect-site concentration using Schnider PKPD model.
Evaluation of basal alpha power preop, at the loss of response time, during de surgery every 20 minutes, and during the first-hour post operatively (in dB)
- Neurological milestones: Montreal Cognitive assessment MoCA test pre and one-hour post-op
- Anesthetic depth: SEDLINE® spectrogram dynamic during anesthetic all process and one hour after using the Patient state Index, the Spectral edge frequency 95, the alpha band power, the existence of Burst suppression,
- Basic monitoring: Electrocardiogram ECG, non-invasive BP, pulse oximetry, and capnography.
Measured: pre, intra and one hour postoperative in recovery room
Presence of post operative delirium and agitation
evaluated by sedation-agitation scale SAS every 30 min, and confusion assessment method CAM ICU scale every 30 min
Measured: post operative in recovery room, and late one week
Secondary outcomes (1)
Postopertive pain
Using the Visual Analog Scale VAS
Measured: in Recovery room evolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start2 Jan 2022
- Primary completion16 May 2022
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging ProblemsStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Principal investigator, Pablo O. Sepulveda, Universidad del Desarrollo
- Investigators
- Pablo Sepulveda V., Dr. Med, Principal investigator, iversidad Austral, Sevicio de salud Valdivia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425069
- Sponsor's protocol ID
- Universidad Austral
- Acronym
- BaseDexmed
- Status last verified
- Jun 2022
- First submitted
- 16 Apr 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publishing in a peer-review journal
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the EEG Connectivity Using Predominantly Dexmedetomidine Anesthesia Versus Traditional TCI Propofol in Fragile Brains
- ClinicalTrials.gov ID
- NCT05425069
- Acronym / sponsor ID
- BaseDexmed / Universidad Austral
- Conditions
- Aging Problems
- Keywords
- Frailty brain, Dexmedetomidine, Propofol, MoCA test, Frontal EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 21 Jun 2022 (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.
Elderly brains that present a lower intrinsic cortical activity are very dependent on arousal feeding. In these patients, a strong blockade of afferences generates a synchronic state with a high tendency to sleep. This is done with drugs such as Dexmedetomidine and its indirect effect of inhibiting the amplification of signals and opioids such as remifentanil. Then, by adding a micro-dose of a gabaergic substance to induce loss of consciousness, unconsciousness would be maintained due to the low requirement of a fragile and synchronous brain by a slow continuous injection of an alpha2 agonist. In previous experience, doses of about one-fifth of the usual would be sufficient to maintain unconsciousness (or perhaps disconnected consciousness that could be useful in avoiding excessive depression in slowed integration pathways). These patients also present deficits in the orexinergic response that manifest themselves in greater neuronal inertia and delayed awakening. Gabaergic drugs (propofol and sevoflurane) are especially depressing to orexinergic nuclei.
This approach to the elderly brain could have an impact on recovering more easily connectivity of those CNC networks.
In elderly patients, one aspect that could control the phenomena of altered connectivity and its impact in developing delirium is the limitation of connection with the environment before the capacity of integration of cortical information has been completely recovered. To analyze frontoparietal connectivity, front frontal coherence, phase lag index, or similar it is necessary to a multichannel EEG (e.g. 10 channels). Otherwise, the frontal EEG from the SEDline monitor device allowed to analyze only spectral characteristics (power, peak frequency, etc.) and correlate them with clinical observations (MoCA).
Detailed description
Research question: Does subcortical drug-based anesthesia allow better recovery of consciousness (integration of information) than the classic gabaergic drug-based technique in elderly and fragile brains?
Primary hypothesis: The anesthetic technique based on subcortical anesthesia with Dexmedetomidine and Remifentanil and minimal gabaergic doses (Propofol) allow fragile and slower brains a faster recovery of cortical connectivity. This behavior represents part of the evidence of neural inertia in sleep and anesthesia.
Objectives:
- Primary: Evaluation of the normalization of the frontal EEG of patients with mostly subcortical anesthesia (Dexmedetomidine-Remifentanil.-low Propofol in TCI ) or classic technique (Remifentanil-Propofol in TCI) versus its preoperative basal control.
- Secondary:
- To estimate the recovery of the cognitive condition with MoCA test, agitation scale, and delirium CAM-ICU.
- To identify behavioral patterns of the EEG with two different anesthetic techniques
Participants
- Target population: Patients scheduled for elective surgery, any sex, non-neurological procedure lasting more than 60 minutes, who do not meet the exclusion criteria.
- Eligibility criteria Inclusion criteria: - ASA I - II - Age: over 70 years old
Exclusion criteria:
- Neurological, or systemic disease that affects the central nervous system in a secondary way
- Abnormal admission neurological physical exam
- Consumption of benzodiazepines, tricyclic antidepressants, sympathomimetics, modafinil, opioid analgesics, histaminergic, antihistamines, cholinergic, anticholinergics, dopaminergic, antidopaminergic, and antihypertensive with alpha-agonist effect in the last 48 hours.
- History of adverse or allergic reactions to Propofol (allergy to soy or any other component of it)
- History of alcohol or drug abuse
- Subjects with "fast sequence induction" indication
Withdrawal criteria:
- Patients presenting with any adverse event during induction (excitation, hypotension, bradycardia <40 x min, nausea).
- Subsequent refusal to participate in the study
- Randomize patients into two groups of a similar number of individuals. Group 1: Propofol TCI - Remifentanil anesthesia. TCI Propofol (Schnider PKPD model), 5-minute step-by-step induction. After LOC stay in this calculated effect site concentration, add Remifentanil TCI PKPD model Minto target 4.5 ng/ml, Rocuronium intubation dose. EEG Sedline monitoring all the surgery until 1 hour postoperatively Group 2: Dexmedetomidine 0.8 ug/kg/h during 10 minutes- then Propofol TCI target 2 ug/ml (Schnidel model) during 3 min and reduce to 0.5 ug/ml, Remifentanil TCI (PK model Minto), after LOC Rocuronium intubation dose. EEG Sedline monitoring all the surgery until 1 hour postoperatively 0,5 ug/ml after LOC
- Both groups were evaluated with MoCA and CAMICU tests: Pre-operative and post-operative cognitive assessments will be performed with MoCA test and CAMICU test, which will be correlated with the EEG characteristics of each group both in the baseline measurements, intraoperative behavior, and after one hour in the recovery room
- Basal frontal EEG with eyes opened and closed (90 sec each) preoperatively without any drug effect
To protect the risk of awareness or excess of EEG depression, during surgery, Anesthesia will be dynamically adjusted to maintain SEF95 remains at minimum values at 8-10 Hz for the rest of the surgery.
Sedline will be maintained for up to 60 min post-op. in the recovery room. Data will be retrieved via pen drive stick (edf data corresponding to raw EEG) and other trends data of the Sedlie monitor using the proprietary software Masimo Instrument Configuration Tools
In both groups, the Systolic Blood Pressure, Freq. Cardiac, Pulse Oximetry, Capnography, and Sedline EEG will be monitored throughout the surgical procedure and for at least one hour postoperatively. No drugs such as ketamine, midazolam, atropine, or other anticholinergics will be used at any time.
Hemodynamics will be supported with volume, ephedrine, or phenylephrine according to the criteria of the anesthesiologist.
Unexpected events during the induction: Any anesthetic induction has risks of hemodynamic instability, arrhythmias, and respiratory apneas. Most of them are easy to handle anesthesiological based on volume, vasoactive drugs such as ephedrine, and respiratory assistance.
In this case, a minimum or no incidence of these is expected because healthy patients are included.
Exceptional situations such as anaphylactic reactions to propofol (very rarely described) will be cause for suspension of the case study and treated with usual protocols for the case.
During the Surgery, the analgesic requirement will be adjusted with Remifentanil TCI concentration in the clinical criterium of the anesthetist.
Postoperative analgesia will be multimodal, with or without regional block depending on the anesthetist's criterium and type of surgery.
Database and data management: SEDLINE data is retrieved online by proprietary software to a PC. These, together with the manual control data, will be collected in a Microsoft Excel 2011 worksheet and exported to a STATA 10 statistical program template, with which the analysis will be performed.
A work together with the Basic Data Manager of the Anesthesia Service to safeguard the information and its confidentiality.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine with minimal concentration of propofol (D-P) | – | Drug: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-PIntravenous infusion with Dexmedetomidine for 10 minutes at 0.8 ug/kg/hr and so on, then induction with Propofol TCI Target 2.0 ug/ml (Schnider model) and Remifentanil TCI 4.5 ng/ml. 3 minutes after LOC Propofol will be reduced to 0.5 ug/ml. intubate using Remifentanil 4.5 ng/ml and Rocuronio 0.5 mg/kg. Anesthesia will be dynamically adjusted to maintain SEF95 remains at minimum values at 10 Hz for the rest of the surgery. Sedline will be maintained for up to 60 min post-op. in the recovery room. Data will be retrieved via pen drive stick from SEdline |
| Propofol TCI fine titrated (P) | – | Drug: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-PBasal frontal EEG with eyes opened and closed (90 sec each) The previous bolus of Lidocaine in a 20 mg intravenous dose, TCI Propofol Induction (Schnider Model) is initiated starting 8 mg/kg/h until clinical unconsciousness (LOC loss of response to the call and to moderate stimulus in the shoulder) and then it is passed to TCI to keep the Ce calculated to the LOC. After LOC, we proceed to intubate using Remifentanil 4.5 ng/ml and Rocuronio. Anesthesia will be dynamically adjusted to maintain Sedline SEF 95 value of minimum at 10Hz. Sedline will be maintained for up to 60 min post LOC in the recovery room. Data will be retrieved via pen drive stick. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients over 70 years, programmed to elective surgery longer than 60 min
Key inclusion criteria (4 listed)
- Eligibility criteria Inclusion criteria
- surgery over 60 min
- ASA I - II
- Age: over 70 years old
Key exclusion criteria (9 listed)
- - Neurological, or systemic disease that affects the central nervous system in a secondary way
- Abnormal admission neurological physical exam
- Consumption of benzodiazepines, tricyclic antidepressants, sympathomimetics, modafinil, opioid analgesics, histaminergic, antihistamines, cholinergic, anticholinergics, dopaminergic, antidopaminergic, and antihypertensive with alpha-agonist effect in the last 48 hours.
- History of adverse or allergic reactions to Propofol (allergy to soy or any other component of it)
- History of alcohol or drug abuse
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 |
|---|---|---|
| Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-PAlso: comparison EEG evolution between study groupsWe compare de impact in EEG, anesthetic condition, and recovery EEG and cognitive clinical characteristic with MoCA test between both groups (propofol vs propofol dexmedetomidine) | Drug | Dexmedetomidine with minimal concentration of propofol (D-P), Propofol TCI fine titrated (P) |
Primary outcome
Comparison of both groups in Recovery Cognitive and electroencephalogram EEG Conditions, during and after surgery
Time frame: pre, intra and one hour postoperative in recovery room
Measuring instruments: Cognitive MoCA test (Montreal Cognitive assessment) pre and one-hour post-operative. Drug consumption to maintain a Spectral Edge Frequency SEF 95 over 10Hz as calculated Propofol effect-site concentration using Schnider PKPD model. Evaluation of basal alpha power preop, at the loss of response time, during de surgery every 20 minutes, and during the first-hour post operatively (in dB) * Neurological milestones: Montreal Cognitive assessment MoCA test pre and one-hour post-op * Anesthetic depth: SEDLINE® spectrogram dynamic during anesthetic all process and one hour after using the Patient state Index, the Spectral edge frequency 95, the alpha band power, the existence of Burst suppression, * Basic monitoring: Electrocardiogram ECG, non-invasive BP, pulse oximetry, and capnography.
Presence of post operative delirium and agitation
Time frame: post operative in recovery room, and late one week
evaluated by sedation-agitation scale SAS every 30 min, and confusion assessment method CAM ICU scale every 30 min
1 secondary outcome
Postopertive pain
Time frame: in Recovery room evolution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided. Publishing in a peer-review journal
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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.
Pablo Sepulveda V., Dr. Med principal investigator
iversidad Austral, Sevicio de salud Valdivia
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 Aging Problems, run by Universidad del Desarrollo at 1 site in Chile.
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 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Fernandez Vega (56632281784, comiteeticasecretaria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of both groups in Recovery Cognitive and electroencephalogram EEG Conditions, during and after surgery (time frame: pre, intra and one hour postoperative in recovery room). The study lists 2 primary outcomes in all. 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 21 Jun 2022.