Postoperative DeliriumNCT04713644
Association Between Burst Suppression During Anesthetic Induction With Postoperative Delirium in Cardiac Surgery
An observational study of Postoperative Delirium, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The population over 65 years of age will be increasingly exposed to surgical procedures that require general anesthesia. Postoperative delirium is one of the main causes of preventable postoperative morbidity in the elderly population and is a frequent event after cardiac surgery with extracorporeal circulation. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Standardized Propofol Administration
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2021to 1 Sep 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 65 years of age undergoing cardiac surgery with cardiopulmonary bypass.
Who may be able to join
- Patients ≥ 65 years of age
- Undergoing elective cardiac surgery requiring extracorporeal circulation (coronary artery bypass, univalvular replacement, bivalvular and coronary artery bypass plus univalvular replacement)
- American Society of Anesthesiologists Physical Status II-III.
Who cannot join
- Body Mass Index > 35 and <18 Kg / m2
- Severe ventricular dysfunction (EF < 30% or severe dysfunction measured in ventriculography)
- Emergency surgery
- Chronic use of alcohol or drug abuse
- History of Stroke
- Neurological diseases
- Endocarditis
- Positive screening for preoperative delirium.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8330024
About this study
Official title: Study of the Association Between Burst Suppression During Anesthetic Induction With Propofol in Cardiac Surgery in Patients Over 65 Years of Age With Postoperative Delirium
The population over 65 years of age will be increasingly exposed to surgical procedures that require general anesthesia. Postoperative delirium is one of the main causes of preventable postoperative morbidity in the elderly population and is a frequent event after cardiac surgery with extracorporeal circulation. The excess administration of anesthetics that potentiate the Gamma Aminobutyric A receptor, such as propofol, are related to an intraoperative electroencephalographic pattern called burst suppression that has been associated with postoperative delirium. It is unknown whether this pattern is secondary to a relative overdose of anesthetics or rather corresponds to a characteristic of a vulnerable brain that is suppressed at doses at which other patients are not. Our objective will be to determine whether burst suppression in people over 65 years of age during a standardized anesthetic induction with propofol for cardiac surgery with extracorporeal circulation is associated with postoperative delirium compared to older people who do not present it.
Read the detailed description
Perioperative neurocognitive disorders, including postoperative delirium (POD), are the leading cause of preventable postoperative morbidity in the elderly population. POD is an acute brain dysfunction characterized by changes in attention and cognition usually within of the first week after surgery and anesthesia. Its appearance triggers a series of events that often end in loss of independence, increased morbidity and mortality and increased health costs. It has been associated with the development of long-term cognitive impairment, including persistent dementia. Its nature is multifactorial and its pathophysiology is not yet fully elucidated.
Over administration of anesthetics that potentiate the Gamma Amino Butyric A (GABAA) receptor, such as barbiturates or propofol, is related to an intraoperative electroencephalographic (EEG) pattern called burst suppression that has been associated with POD. It is a common event after cardiac surgery with an incidence ranging from 15% to 50%. Given its adverse impact on functioning and quality of life, delirium has enormous social implications for the individual, family, community, and health care systems.
Burst suppression is a pattern observed in the EEG characterized by quasi-periodic alternations between isoelectricity (flat EEG) and brief bursts of electrical activity such as spikes, sharp waves, or slow waves. It reflects a brain state of relative cortical inactivity that is not observed during normal waking states or sleeping behaviors. This pattern can be observed associated with coma due to diffuse anoxic damage, induced hypothermia and Ohtahara syndrome epilepsy. In addition, the administration of high-dose anesthetics that potentiate the GABAA receptor produce burst suppression followed by isoelectricity. Burst suppression during maintenance of general anesthesia with anesthetics that enhance the GABAA receptor has previously been associated with POD. When propofol is administered as a bolus during anesthetic induction, older patients, can suffer burst suppression in seconds. However, it is unknown whether this pattern is secondary to a relative overdose of anesthetics or rather corresponds to a characteristic of the vulnerable brain that is suppressed at doses to which other patients do not present this pattern. At present, it is not known whether burst suppression is a modifiable risk factor for POD or an epiphenomenon or marker of other factors that cause POD. A randomized controlled clinical trial studied an EEG-guided anesthetic protocol that reduced the administration of anesthetic, diminished the incidence of burts suppression during the intraoperative period, but not the incidence of POD. Therefore, the association between bursts suppression induced by anesthetics and POD appears not to be causal.
- Conditions
- Postoperative Delirium
- Being tested
- Standardized Propofol Administration
- Keywords
- Burst Suppression, Postoperative Delirium, Electroencephalography, Propofol, Cardiac Surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Propofol AdministrationDrug
Intravenous bolus propofol administration of 0.5 mg/Kg dose, plus 0.5 mg/Kg extra if necessary
| Study group | Role | What they receive |
|---|---|---|
| Burst Suppression | Patients who present burst suppression after standardized propofol administration during anesthetic induction Receives: Drug: Standardized Propofol Administration | |
| No Burst Suppression | Patients who did not present burst suppression after standardized propofol administration during anesthetic induction Receives: Drug: Standardized Propofol Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
Positive Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), or structured chart review
Measured: Up to 72 hours after surgery (3 postoperative days), CAM or CAM-ICU assessed twice daily (AM/PM)
Secondary outcomes (6)
Burst suppression during anesthesia induction
Burst suppression incidence after standardized propofol induction in patients ≥ 65 years scheduled for cardiac surgery with cardiopulmonary bypass
Measured: 20 minutes after standardized propofol administration
Burst suppression during cardiopulmonary bypass
Burst suppression incidence during cardiopulmonary bypass in patients ≥ 65 years scheduled for cardiac surgery with cardiopulmonary bypass
Measured: Through Cardiopulmonary bypass time defined as time between connection to pump to disconnection, an average of 120 minutes
Preoperative Cognitive Status
Preoperative cognitive assessment using MiniCog, minimum value: 0 - maximum value:5 , higher scores meaning better outcomes. If MiniCog ≤ 2, MoCA (Montreal Cognitive Assessment) exam will be performed.
Measured: Preoperative anesthetic evaluation
Preoperative Frailty
Preoperative frailty evaluation using Clinical Frailty Scale (CFS), minimum value: 1(Very Fit) - maximum value: 9 (Terminally Ill), higher scores meaning worse outcomes
Measured: Preoperative anesthetic evaluation
Electroencephalogram (EEG) Alpha Power/Total Power
Electroencephalogram power between 8 to 12 Hz (Alpha) and 0.1 to 35 Hz (Total)
Measured: Stable anesthetic period before cardiopulmonary bypass and 20 minutes after propofol induction
CRP (C Reactive Protein)
Serum C Reactive Protein
Measured: Blood sample collection during arterial line insertion, before anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Mar 2021
- Primary completion28 Feb 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan C Pedemonte, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713644
- Sponsor's protocol ID
- 200923005
- Status last verified
- Nov 2024
- First submitted
- 11 Jan 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be collected and saved in digital forms. Data may be shared with other researchers with previous authorization from the PI.
Publications
Soreide K, Wijnhoven BP. Surgery for an ageing population. Br J Surg. 2016 Jan;103(2):e7-9. doi: 10.1002/bjs.10071. No abstract available.
PubMed 26771471Deiner S, Westlake B, Dutton RP. Patterns of surgical care and complications in elderly adults. J Am Geriatr Soc. 2014 May;62(5):829-35. doi: 10.1111/jgs.12794. Epub 2014 Apr 14.
PubMed 24731176Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
PubMed 28973626Boone MD, Sites B, von Recklinghausen FM, Mueller A, Taenzer AH, Shaefi S. Economic Burden of Postoperative Neurocognitive Disorders Among US Medicare Patients. JAMA Netw Open. 2020 Jul 1;3(7):e208931. doi: 10.1001/jamanetworkopen.2020.8931.
PubMed 32735336Oh ES, Akeju O, Avidan MS, Cunningham C, Hayden KM, Jones RN, Khachaturian AS, Khan BA, Marcantonio ER, Needham DM, Neufeld KJ, Rose L, Spence J, Tieges Z, Vlisides P, Inouye SK; NIDUS Writing Group. A roadmap to advance delirium research: Recommendations from the NIDUS Scientific Think Tank. Alzheimers Dement. 2020 May;16(5):726-733. doi: 10.1002/alz.12076. Epub 2020 Apr 14.
PubMed 32291901Goldberg TE, Chen C, Wang Y, Jung E, Swanson A, Ing C, Garcia PS, Whittington RA, Moitra V. Association of Delirium With Long-term Cognitive Decline: A Meta-analysis. JAMA Neurol. 2020 Nov 1;77(11):1373-1381. doi: 10.1001/jamaneurol.2020.2273.
PubMed 32658246Berger M, Terrando N, Smith SK, Browndyke JN, Newman MF, Mathew JP. Neurocognitive Function after Cardiac Surgery: From Phenotypes to Mechanisms. Anesthesiology. 2018 Oct;129(4):829-851. doi: 10.1097/ALN.0000000000002194.
PubMed 29621031Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
PubMed 26418126Fritz BA, Maybrier HR, Avidan MS. Intraoperative electroencephalogram suppression at lower volatile anaesthetic concentrations predicts postoperative delirium occurring in the intensive care unit. Br J Anaesth. 2018 Jul;121(1):241-248. doi: 10.1016/j.bja.2017.10.024. Epub 2018 Jan 17.
PubMed 29935578Pedemonte JC, Plummer GS, Chamadia S, Locascio JJ, Hahm E, Ethridge B, Gitlin J, Ibala R, Mekonnen J, Colon KM, Westover MB, D'Alessandro DA, Tolis G, Houle T, Shelton KT, Qu J, Akeju O. Electroencephalogram Burst-suppression during Cardiopulmonary Bypass in Elderly Patients Mediates Postoperative Delirium. Anesthesiology. 2020 Aug;133(2):280-292. doi: 10.1097/ALN.0000000000003328.
PubMed 32349072Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.
PubMed 25928189Brown CH 4th, Max L, LaFlam A, Kirk L, Gross A, Arora R, Neufeld K, Hogue CW, Walston J, Pustavoitau A. The Association Between Preoperative Frailty and Postoperative Delirium After Cardiac Surgery. Anesth Analg. 2016 Aug;123(2):430-5. doi: 10.1213/ANE.0000000000001271.
PubMed 27096563Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
PubMed 26275092Plummer GS, Ibala R, Hahm E, An J, Gitlin J, Deng H, Shelton KT, Solt K, Qu JZ, Akeju O. Electroencephalogram dynamics during general anesthesia predict the later incidence and duration of burst-suppression during cardiopulmonary bypass. Clin Neurophysiol. 2019 Jan;130(1):55-60. doi: 10.1016/j.clinph.2018.11.003. Epub 2018 Nov 16.
PubMed 30476711
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between Burst Suppression During Anesthetic Induction With Propofol in Cardiac Surgery in Patients Over 65 Years of Age With Postoperative Delirium
- ClinicalTrials.gov ID
- NCT04713644
- Acronym / sponsor ID
- 200923005
- Conditions
- Postoperative Delirium
- Keywords
- Burst Suppression, Postoperative Delirium, Electroencephalography, Propofol, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Jan 2021 (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.
The population over 65 years of age will be increasingly exposed to surgical procedures that require general anesthesia. Postoperative delirium is one of the main causes of preventable postoperative morbidity in the elderly population and is a frequent event after cardiac surgery with extracorporeal circulation. The excess administration of anesthetics that potentiate the Gamma Aminobutyric A receptor, such as propofol, are related to an intraoperative electroencephalographic pattern called burst suppression that has been associated with postoperative delirium. It is unknown whether this pattern is secondary to a relative overdose of anesthetics or rather corresponds to a characteristic of a vulnerable brain that is suppressed at doses at which other patients are not. Our objective will be to determine whether burst suppression in people over 65 years of age during a standardized anesthetic induction with propofol for cardiac surgery with extracorporeal circulation is associated with postoperative delirium compared to older people who do not present it.
Detailed description
Perioperative neurocognitive disorders, including postoperative delirium (POD), are the leading cause of preventable postoperative morbidity in the elderly population. POD is an acute brain dysfunction characterized by changes in attention and cognition usually within of the first week after surgery and anesthesia. Its appearance triggers a series of events that often end in loss of independence, increased morbidity and mortality and increased health costs. It has been associated with the development of long-term cognitive impairment, including persistent dementia. Its nature is multifactorial and its pathophysiology is not yet fully elucidated.
Over administration of anesthetics that potentiate the Gamma Amino Butyric A (GABAA) receptor, such as barbiturates or propofol, is related to an intraoperative electroencephalographic (EEG) pattern called burst suppression that has been associated with POD. It is a common event after cardiac surgery with an incidence ranging from 15% to 50%. Given its adverse impact on functioning and quality of life, delirium has enormous social implications for the individual, family, community, and health care systems.
Burst suppression is a pattern observed in the EEG characterized by quasi-periodic alternations between isoelectricity (flat EEG) and brief bursts of electrical activity such as spikes, sharp waves, or slow waves. It reflects a brain state of relative cortical inactivity that is not observed during normal waking states or sleeping behaviors. This pattern can be observed associated with coma due to diffuse anoxic damage, induced hypothermia and Ohtahara syndrome epilepsy. In addition, the administration of high-dose anesthetics that potentiate the GABAA receptor produce burst suppression followed by isoelectricity. Burst suppression during maintenance of general anesthesia with anesthetics that enhance the GABAA receptor has previously been associated with POD. When propofol is administered as a bolus during anesthetic induction, older patients, can suffer burst suppression in seconds. However, it is unknown whether this pattern is secondary to a relative overdose of anesthetics or rather corresponds to a characteristic of the vulnerable brain that is suppressed at doses to which other patients do not present this pattern. At present, it is not known whether burst suppression is a modifiable risk factor for POD or an epiphenomenon or marker of other factors that cause POD. A randomized controlled clinical trial studied an EEG-guided anesthetic protocol that reduced the administration of anesthetic, diminished the incidence of burts suppression during the intraoperative period, but not the incidence of POD. Therefore, the association between bursts suppression induced by anesthetics and POD appears not to be causal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burst Suppression | – | Drug: Standardized Propofol AdministrationPatients who present burst suppression after standardized propofol administration during anesthetic induction |
| No Burst Suppression | – | Drug: Standardized Propofol AdministrationPatients who did not present burst suppression after standardized propofol administration during anesthetic induction |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 65 years of age undergoing cardiac surgery with cardiopulmonary bypass.
Key inclusion criteria (3 listed)
- Patients ≥ 65 years of age
- Undergoing elective cardiac surgery requiring extracorporeal circulation (coronary artery bypass, univalvular replacement, bivalvular and coronary artery bypass plus univalvular replacement)
- American Society of Anesthesiologists Physical Status II-III.
Key exclusion criteria (8 listed)
- Body Mass Index > 35 and <18 Kg / m2
- Severe ventricular dysfunction (EF < 30% or severe dysfunction measured in ventriculography)
- Emergency surgery
- Chronic use of alcohol or drug abuse
- History of Stroke
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 |
|---|---|---|
| Standardized Propofol AdministrationIntravenous bolus propofol administration of 0.5 mg/Kg dose, plus 0.5 mg/Kg extra if necessary | Drug | Burst Suppression, No Burst Suppression |
Primary outcome
Postoperative Delirium
Time frame: Up to 72 hours after surgery (3 postoperative days), CAM or CAM-ICU assessed twice daily (AM/PM)
Positive Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), or structured chart review
6 secondary outcomes
Burst suppression during anesthesia induction
Time frame: 20 minutes after standardized propofol administration
Burst suppression during cardiopulmonary bypass
Time frame: Through Cardiopulmonary bypass time defined as time between connection to pump to disconnection, an average of 120 minutes
Preoperative Cognitive Status
Time frame: Preoperative anesthetic evaluation
Preoperative Frailty
Time frame: Preoperative anesthetic evaluation
Electroencephalogram (EEG) Alpha Power/Total Power
Time frame: Stable anesthetic period before cardiopulmonary bypass and 20 minutes after propofol induction
CRP (C Reactive Protein)
Time frame: Blood sample collection during arterial line insertion, before anesthetic induction
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 31 May 2025.
- Background: PubMed 26771471Soreide K, Wijnhoven BP. Surgery for an ageing population. Br J Surg. 2016 Jan;103(2):e7-9. doi: 10.1002/bjs.10071. No abstract available.
- Background: PubMed 24731176Deiner S, Westlake B, Dutton RP. Patterns of surgical care and complications in elderly adults. J Am Geriatr Soc. 2014 May;62(5):829-35. doi: 10.1111/jgs.12794. Epub 2014 Apr 14.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Background: PubMed 28973626Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
- Background: PubMed 32735336Boone MD, Sites B, von Recklinghausen FM, Mueller A, Taenzer AH, Shaefi S. Economic Burden of Postoperative Neurocognitive Disorders Among US Medicare Patients. JAMA Netw Open. 2020 Jul 1;3(7):e208931. doi: 10.1001/jamanetworkopen.2020.8931.
- Background: PubMed 32291901Oh ES, Akeju O, Avidan MS, Cunningham C, Hayden KM, Jones RN, Khachaturian AS, Khan BA, Marcantonio ER, Needham DM, Neufeld KJ, Rose L, Spence J, Tieges Z, Vlisides P, Inouye SK; NIDUS Writing Group. A roadmap to advance delirium research: Recommendations from the NIDUS Scientific Think Tank. Alzheimers Dement. 2020 May;16(5):726-733. doi: 10.1002/alz.12076. Epub 2020 Apr 14.
- Background: PubMed 32658246Goldberg TE, Chen C, Wang Y, Jung E, Swanson A, Ing C, Garcia PS, Whittington RA, Moitra V. Association of Delirium With Long-term Cognitive Decline: A Meta-analysis. JAMA Neurol. 2020 Nov 1;77(11):1373-1381. doi: 10.1001/jamaneurol.2020.2273.
- Background: PubMed 29621031Berger M, Terrando N, Smith SK, Browndyke JN, Newman MF, Mathew JP. Neurocognitive Function after Cardiac Surgery: From Phenotypes to Mechanisms. Anesthesiology. 2018 Oct;129(4):829-851. doi: 10.1097/ALN.0000000000002194.
- Background: PubMed 26418126Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
- Background: PubMed 29935578Fritz BA, Maybrier HR, Avidan MS. Intraoperative electroencephalogram suppression at lower volatile anaesthetic concentrations predicts postoperative delirium occurring in the intensive care unit. Br J Anaesth. 2018 Jul;121(1):241-248. doi: 10.1016/j.bja.2017.10.024. Epub 2018 Jan 17.
- Background: PubMed 32349072Pedemonte JC, Plummer GS, Chamadia S, Locascio JJ, Hahm E, Ethridge B, Gitlin J, Ibala R, Mekonnen J, Colon KM, Westover MB, D'Alessandro DA, Tolis G, Houle T, Shelton KT, Qu J, Akeju O. Electroencephalogram Burst-suppression during Cardiopulmonary Bypass in Elderly Patients Mediates Postoperative Delirium. Anesthesiology. 2020 Aug;133(2):280-292. doi: 10.1097/ALN.0000000000003328.
- Background: PubMed 25928189Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.
- Individual participant dataSharing planned: Undecided. All data will be collected and saved in digital forms. Data may be shared with other researchers with previous authorization from the PI.
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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.
Juan C Pedemonte, MD principal investigator
Pontificia Universidad Catolica de Chile
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 Postoperative Delirium, run by Pontificia Universidad Catolica de Chile 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 3 inclusion and 8 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 31 May 2025. 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?
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?
Postoperative Delirium (time frame: Up to 72 hours after surgery (3 postoperative days), CAM or CAM-ICU assessed twice daily (AM/PM)). 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 NCT04713644, which also lists 18 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 31 May 2025.