Critically Ill PatientsNCT07583732
BIS in Critically Ill Patients in ICU
A study testing Processed EEG monitoring in people with Critically Ill Patients, run by Mahidol University at 1 site in Thailand.
Trial summary
The Bispectral Index (BIS) is a monitor that converts brain electrical activity from EEG into a simple number from 0 to 100. A higher number means the patient is more awake, while a lower number means deeper sedation or reduced brain activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- Processed EEG monitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 15 May 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18years
- RASS score ≤ -3 as case
- RASS score 0 to -1 as control
- Expected ICU length of stays ≥ 24hours
Who cannot join
- Contraindication for BIS monitoring (wound or infection at forehead)
- No space for attach BIS monitoring at forehead
- Patient with sedative drugs (Propofol, Midazolam, Dexmedetomidine)
- Patient with acute stroke
- Patient was already on EEG monitoring
- Denied by patients or patient's surrogates
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Annop Piriyapatsom, M.D., +66 2419 7990, annop.pir@mahidol.ac.th
Annop Piriyapatsom, M.D.
About this study
Official title: The Comparison of Bispectral Index Parameter Between Critically Ill Patients With and Without Decreased Mental Status and Its Association With Clinical Outcomes
The Bispectral Index (BIS) is a monitor that converts brain electrical activity from EEG into a simple number from 0 to 100. A higher number means the patient is more awake, while a lower number means deeper sedation or reduced brain activity.
In general, 100 means fully awake, 80 suggests light to moderate sedation, 60 is commonly used as a target for general anesthesia with a low chance of awareness, 40 indicates deep anesthesia, 20 suggests marked brain suppression with burst suppression on EEG, and 0 indicates no detectable cortical electrical activity.
Although BIS was originally developed for use in the operating room, it has also been applied in the ICU to help guide sedation, avoid over- or under-sedation, and assess consciousness in patients who cannot be evaluated reliably using standard clinical scores. BIS has also been studied as a possible tool for predicting outcomes in comatose ICU patients, such as those after cardiac arrest, stroke, encephalitis, or traumatic brain injury. However, evidence is still limited for its use in predicting outcomes among ICU patients with any form of decreased consciousness. Therefore, this study was conducted to explore that role.
Read the detailed description
The Bispectral Index is the output of a multi-stage process that transforms the brain's electrical activity into a simplified metric. This process begins with non-invasive data acquisition and proceeds through advanced computational analysis to derive the final index.
The BIS monitor translates the EEG data into a number on a scale from 0 to 100. This index is designed to provide a direct measure of a patient's level of consciousness and response to sedation, with specific numeric ranges corresponding to general clinical states.
The generally accepted clinical correlations for the BIS scale are as follows:
- 100: This value indicates a patient who is fully awake and alert, corresponding to a state of responsiveness to a normal voice.
- 80: This range is typically associated with light to moderate sedation or anxiolysis. A patient in this range may respond to loud verbal commands or mild physical stimulation, such as prodding or shaking.
- 60: This value is a critical threshold often targeted for general anesthesia. It represents a low probability of explicit recall and unresponsiveness to verbal stimuli. A BIS value of less than 60 has a high sensitivity for identifying a state of drug-induced unconsciousness, making it a key target in the operating room to prevent awareness.
- 40: This range signifies a deep hypnotic state, with a greater degree of cortical suppression than is typically required for general anesthesia.
- 20: A BIS value in this range indicates the presence of burst suppression on the EEG. This pattern, characterized by periods of electrical activity (bursts) alternating with periods of isoelectricity (suppression), reflects a very deep level of brain suppression seen with high doses of anesthetic agents or in conditions like barbiturate coma or severe anoxic brain injury.
- 0: A BIS value of 0 represents a flatline or isoelectric EEG, indicating the absence of detectable cortical electrical activity.
BIS monitoring was adapted from the operating room to the ICU to help manage the difficult task of sedating critically ill patients.
Its main goals in the ICU are to:
- Prevent the risks of over- or under-sedation.
- Provide an objective number to guide medication dosage.
- Assess consciousness in patients who can't be evaluated by normal methods. BIS monitoring is being used more frequently to assess the depth of sedation in ICU patients, as opposed to relying solely on clinical scoring systems.
The Bispectral Index (BIS) has been used to predict clinical outcomes in ICU patients with coma from various causes, including post-cardiac arrest, cerebrovascular disease, viral encephalitis, and traumatic brain injury. However, there is limited research on using BIS to predict outcomes for patients with any decreased level of consciousness in the ICU. Therefore, this study was initiated.
- Conditions
- Critically Ill Patients
- Being tested
- Processed EEG monitoring
- Keywords
- BIS, processed EEG, ICU patient, Sedation, Neuromonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed EEG monitoringOther
Monitor processed EEG using BIS
| Study group | Role | What they receive |
|---|---|---|
| Decreased mental status | Active comparator | Decreased mental status Receives: Other: Processed EEG monitoring |
| Normal mental status | Placebo comparator | Normal mental status Receives: Other: Processed EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS value
Average BIS value during 24 hours period of monitoring
Measured: 24 hours following inclusion
Secondary outcomes (8)
Length of stay in SICU
Total days of stay in SICU
Measured: Up to 90 days following inclusion
Length of stay in hospital
Total days of stay in hospital
Measured: Up to 90 days following inclusion
SICU discharge status
Status whether alive or decease
Measured: Up to 90 days following inclusion
Hospital discharge status
Status whether alive or decease
Measured: Up to 90 days following inclusion
Status at 30 days
Status whether alive or decease
Measured: Up to 30 days following inclusion
Status at 90 days
Status whether alive or decease
Measured: Up to 90 days following inclusion
ICU Memory
ICU Memory Tool:
Three domains: ICU environment (family, alarms, tubes), feelings (pain, agitation, confusion), delusions (dreams, hallucinations).
A self-rated format for frequency, ranging from 0 to 2 (never, sometimes, and often).
Measured: Up to 90 days following inclusion
Post-traumatic Stress Disorder
Post-traumatic Stress Disorder (PTSD) assessed by Impact of Event scale (IES)-6 which comprised 6 questions, each scored from 0 to 4 (Not at all, a little bit, moderately, quite a bit, extremely). Mean IES-6 score ≥ 1.75 considers positive screening for PTSD.
Measured: Up to 90 days following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583732
- Sponsor's protocol ID
- 037/2569(IRB1)
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Misis M, Raxach JG, Molto HP, Vega SM, Rico PS. Bispectral index monitoring for early detection of brain death. Transplant Proc. 2008 Jun;40(5):1279-81. doi: 10.1016/j.transproceed.2008.03.145.
PubMed 18589087Vivien B, Paqueron X, Le Cosquer P, Langeron O, Coriat P, Riou B. Detection of brain death onset using the bispectral index in severely comatose patients. Intensive Care Med. 2002 Apr;28(4):419-25. doi: 10.1007/s00134-002-1219-4. Epub 2002 Mar 19.
PubMed 11967595Dou L, Gao HM, Lu L, Chang WX. Bispectral index in predicting the prognosis of patients with coma in intensive care unit. World J Emerg Med. 2014;5(1):53-6. doi: 10.5847/wjem.j.issn.1920-8642.2014.01.009.
PubMed 25215148Arbas-Redondo E, Rosillo-Rodriguez SO, Merino-Argos C, Marco-Clement I, Rodriguez-Sotelo L, Martinez-Marin LA, Martin-Polo L, Velez-Salas A, Caro-Codon J, Garcia-Arribas D, Armada-Romero E, Lopez-De-Sa E. Bispectral index and suppression ratio after cardiac arrest: are they useful as bedside tools for rational treatment escalation plans? Rev Esp Cardiol (Engl Ed). 2022 Dec;75(12):992-1000. doi: 10.1016/j.rec.2022.03.004. Epub 2022 May 12. English, Spanish.
PubMed 35570124Heavner MS, Gorman EF, Linn DD, Yeung SYA, Miano TA. Systematic review and meta-analysis of the correlation between bispectral index (BIS) and clinical sedation scales: Toward defining the role of BIS in critically ill patients. Pharmacotherapy. 2022 Aug;42(8):667-676. doi: 10.1002/phar.2712. Epub 2022 Jun 30.
PubMed 35707961Huespe I, Giunta D, Acosta K, Avila D, Prado E, Sanghavi D, Bisso IC, Giannasi S, Carini FC. Comparing Bispectral Index Monitoring vs Clinical Assessment for Deep Sedation in the ICU: Effects on Delirium Reduction and Sedative Drug Doses-A Randomized Trial. Chest. 2024 Oct;166(4):733-742. doi: 10.1016/j.chest.2024.05.031. Epub 2024 Jun 18.
PubMed 38901489Tasaka CL, Duby JJ, Pandya K, Wilson MD, A Hardin K. Inadequate Sedation During Therapeutic Paralysis: Use of Bispectral Index in Critically Ill Patients. Drugs Real World Outcomes. 2016 May 28;3(2):201-208. doi: 10.1007/s40801-016-0076-3. eCollection 2016 Jun.
PubMed 27398299Manning J, Chiasson M. Does Bispectral Index Monitoring Belong in the Intensive Care Unit Setting?: A Narrative Review of Evidence. Dimens Crit Care Nurs. 2025 Sep-Oct 01;44(5):231-238. doi: 10.1097/DCC.0000000000000713.
PubMed 40719578Eertmans W, Genbrugge C, Vander Laenen M, Boer W, Mesotten D, Dens J, Jans F, De Deyne C. The prognostic value of bispectral index and suppression ratio monitoring after out-of-hospital cardiac arrest: a prospective observational study. Ann Intensive Care. 2018 Mar 2;8(1):34. doi: 10.1186/s13613-018-0380-z.
PubMed 29500559Selig C, Riegger C, Dirks B, Pawlik M, Seyfried T, Klingler W. Bispectral index (BIS) and suppression ratio (SR) as an early predictor of unfavourable neurological outcome after cardiac arrest. Resuscitation. 2014 Feb;85(2):221-6. doi: 10.1016/j.resuscitation.2013.11.008. Epub 2013 Nov 25.
PubMed 24287327Perez-Otal B, Aragon-Benedi C, Pascual-Bellosta A, Ortega-Lucea S, Martinez-Ubieto J, Ramirez-Rodriguez JM; Research Group in Anaesthesia, Resuscitation, and Perioperative Medicine of Institute for Health Research Aragon (ISS Aragon). Neuromonitoring depth of anesthesia and its association with postoperative delirium. Sci Rep. 2022 Jul 26;12(1):12703. doi: 10.1038/s41598-022-16466-y.
PubMed 35882875Yang Y, Song C, Song C, Li C. Comparison of Bispectral Index-Guided Individualized Anesthesia with Standard General Anesthesia on Inadequate Emergence and Postoperative Delirium in Elderly Patients Undergoing Esophagectomy: A Retrospective Study at a Single Center. Med Sci Monit. 2020 Oct 1;26:e925314. doi: 10.12659/MSM.925314.
PubMed 33001868Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
PubMed 18337600Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
PubMed 15172773Riddell JR, Fernandes BM, Jadav RH, Wise MP. Monitoring Sedation Depth in Critical Illness, State-of-the-Art Practice. Crit Care Clin. 2025 Oct;41(4):707-720. doi: 10.1016/j.ccc.2025.06.001. Epub 2025 Jul 14.
PubMed 41101833
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Bispectral Index Parameter Between Critically Ill Patients With and Without Decreased Mental Status and Its Association With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07583732
- Acronym / sponsor ID
- 037/2569(IRB1)
- Conditions
- Critically Ill Patients
- Keywords
- BIS, processed EEG, ICU patient, Sedation, Neuromonitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 May 2026 (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 Bispectral Index (BIS) is a monitor that converts brain electrical activity from EEG into a simple number from 0 to 100. A higher number means the patient is more awake, while a lower number means deeper sedation or reduced brain activity.
In general, 100 means fully awake, 80 suggests light to moderate sedation, 60 is commonly used as a target for general anesthesia with a low chance of awareness, 40 indicates deep anesthesia, 20 suggests marked brain suppression with burst suppression on EEG, and 0 indicates no detectable cortical electrical activity.
Although BIS was originally developed for use in the operating room, it has also been applied in the ICU to help guide sedation, avoid over- or under-sedation, and assess consciousness in patients who cannot be evaluated reliably using standard clinical scores. BIS has also been studied as a possible tool for predicting outcomes in comatose ICU patients, such as those after cardiac arrest, stroke, encephalitis, or traumatic brain injury. However, evidence is still limited for its use in predicting outcomes among ICU patients with any form of decreased consciousness. Therefore, this study was conducted to explore that role.
Detailed description
The Bispectral Index is the output of a multi-stage process that transforms the brain's electrical activity into a simplified metric. This process begins with non-invasive data acquisition and proceeds through advanced computational analysis to derive the final index.
The BIS monitor translates the EEG data into a number on a scale from 0 to 100. This index is designed to provide a direct measure of a patient's level of consciousness and response to sedation, with specific numeric ranges corresponding to general clinical states.
The generally accepted clinical correlations for the BIS scale are as follows:
- 100: This value indicates a patient who is fully awake and alert, corresponding to a state of responsiveness to a normal voice.
- 80: This range is typically associated with light to moderate sedation or anxiolysis. A patient in this range may respond to loud verbal commands or mild physical stimulation, such as prodding or shaking.
- 60: This value is a critical threshold often targeted for general anesthesia. It represents a low probability of explicit recall and unresponsiveness to verbal stimuli. A BIS value of less than 60 has a high sensitivity for identifying a state of drug-induced unconsciousness, making it a key target in the operating room to prevent awareness.
- 40: This range signifies a deep hypnotic state, with a greater degree of cortical suppression than is typically required for general anesthesia.
- 20: A BIS value in this range indicates the presence of burst suppression on the EEG. This pattern, characterized by periods of electrical activity (bursts) alternating with periods of isoelectricity (suppression), reflects a very deep level of brain suppression seen with high doses of anesthetic agents or in conditions like barbiturate coma or severe anoxic brain injury.
- 0: A BIS value of 0 represents a flatline or isoelectric EEG, indicating the absence of detectable cortical electrical activity.
BIS monitoring was adapted from the operating room to the ICU to help manage the difficult task of sedating critically ill patients.
Its main goals in the ICU are to:
- Prevent the risks of over- or under-sedation.
- Provide an objective number to guide medication dosage.
- Assess consciousness in patients who can't be evaluated by normal methods. BIS monitoring is being used more frequently to assess the depth of sedation in ICU patients, as opposed to relying solely on clinical scoring systems.
The Bispectral Index (BIS) has been used to predict clinical outcomes in ICU patients with coma from various causes, including post-cardiac arrest, cerebrovascular disease, viral encephalitis, and traumatic brain injury. However, there is limited research on using BIS to predict outcomes for patients with any decreased level of consciousness in the ICU. Therefore, this study was initiated.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decreased mental status | Active comparator | Other: Processed EEG monitoringDecreased mental status |
| Normal mental status | Placebo comparator | Other: Processed EEG monitoringNormal mental status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18years
- RASS score ≤ -3 as case
- RASS score 0 to -1 as control
- Expected ICU length of stays ≥ 24hours
Key exclusion criteria (6 listed)
- Contraindication for BIS monitoring (wound or infection at forehead)
- No space for attach BIS monitoring at forehead
- Patient with sedative drugs (Propofol, Midazolam, Dexmedetomidine)
- Patient with acute stroke
- Patient was already on EEG monitoring
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 |
|---|---|---|
| Processed EEG monitoringMonitor processed EEG using BIS | Other | Decreased mental status, Normal mental status |
Primary outcome
BIS value
Time frame: 24 hours following inclusion
Average BIS value during 24 hours period of monitoring
8 secondary outcomes
Length of stay in SICU
Time frame: Up to 90 days following inclusion
Length of stay in hospital
Time frame: Up to 90 days following inclusion
SICU discharge status
Time frame: Up to 90 days following inclusion
Hospital discharge status
Time frame: Up to 90 days following inclusion
Status at 30 days
Time frame: Up to 30 days following inclusion
Status at 90 days
Time frame: Up to 90 days following inclusion
ICU Memory
Time frame: Up to 90 days following inclusion
Post-traumatic Stress Disorder
Time frame: Up to 90 days following inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 18589087Misis M, Raxach JG, Molto HP, Vega SM, Rico PS. Bispectral index monitoring for early detection of brain death. Transplant Proc. 2008 Jun;40(5):1279-81. doi: 10.1016/j.transproceed.2008.03.145.
- Results publication: PubMed 11967595Vivien B, Paqueron X, Le Cosquer P, Langeron O, Coriat P, Riou B. Detection of brain death onset using the bispectral index in severely comatose patients. Intensive Care Med. 2002 Apr;28(4):419-25. doi: 10.1007/s00134-002-1219-4. Epub 2002 Mar 19.
- Results publication: PubMed 25215148Dou L, Gao HM, Lu L, Chang WX. Bispectral index in predicting the prognosis of patients with coma in intensive care unit. World J Emerg Med. 2014;5(1):53-6. doi: 10.5847/wjem.j.issn.1920-8642.2014.01.009.
- Results publication: PubMed 35570124Arbas-Redondo E, Rosillo-Rodriguez SO, Merino-Argos C, Marco-Clement I, Rodriguez-Sotelo L, Martinez-Marin LA, Martin-Polo L, Velez-Salas A, Caro-Codon J, Garcia-Arribas D, Armada-Romero E, Lopez-De-Sa E. Bispectral index and suppression ratio after cardiac arrest: are they useful as bedside tools for rational treatment escalation plans? Rev Esp Cardiol (Engl Ed). 2022 Dec;75(12):992-1000. doi: 10.1016/j.rec.2022.03.004. Epub 2022 May 12. English, Spanish.
- Results publication: PubMed 35707961Heavner MS, Gorman EF, Linn DD, Yeung SYA, Miano TA. Systematic review and meta-analysis of the correlation between bispectral index (BIS) and clinical sedation scales: Toward defining the role of BIS in critically ill patients. Pharmacotherapy. 2022 Aug;42(8):667-676. doi: 10.1002/phar.2712. Epub 2022 Jun 30.
- Results publication: PubMed 38901489Huespe I, Giunta D, Acosta K, Avila D, Prado E, Sanghavi D, Bisso IC, Giannasi S, Carini FC. Comparing Bispectral Index Monitoring vs Clinical Assessment for Deep Sedation in the ICU: Effects on Delirium Reduction and Sedative Drug Doses-A Randomized Trial. Chest. 2024 Oct;166(4):733-742. doi: 10.1016/j.chest.2024.05.031. Epub 2024 Jun 18.
- Results publication: PubMed 27398299Tasaka CL, Duby JJ, Pandya K, Wilson MD, A Hardin K. Inadequate Sedation During Therapeutic Paralysis: Use of Bispectral Index in Critically Ill Patients. Drugs Real World Outcomes. 2016 May 28;3(2):201-208. doi: 10.1007/s40801-016-0076-3. eCollection 2016 Jun.
- Results publication: PubMed 40719578Manning J, Chiasson M. Does Bispectral Index Monitoring Belong in the Intensive Care Unit Setting?: A Narrative Review of Evidence. Dimens Crit Care Nurs. 2025 Sep-Oct 01;44(5):231-238. doi: 10.1097/DCC.0000000000000713.
- Results publication: PubMed 29500559Eertmans W, Genbrugge C, Vander Laenen M, Boer W, Mesotten D, Dens J, Jans F, De Deyne C. The prognostic value of bispectral index and suppression ratio monitoring after out-of-hospital cardiac arrest: a prospective observational study. Ann Intensive Care. 2018 Mar 2;8(1):34. doi: 10.1186/s13613-018-0380-z.
- Results publication: PubMed 24287327Selig C, Riegger C, Dirks B, Pawlik M, Seyfried T, Klingler W. Bispectral index (BIS) and suppression ratio (SR) as an early predictor of unfavourable neurological outcome after cardiac arrest. Resuscitation. 2014 Feb;85(2):221-6. doi: 10.1016/j.resuscitation.2013.11.008. Epub 2013 Nov 25.
- Results publication: PubMed 35882875Perez-Otal B, Aragon-Benedi C, Pascual-Bellosta A, Ortega-Lucea S, Martinez-Ubieto J, Ramirez-Rodriguez JM; Research Group in Anaesthesia, Resuscitation, and Perioperative Medicine of Institute for Health Research Aragon (ISS Aragon). Neuromonitoring depth of anesthesia and its association with postoperative delirium. Sci Rep. 2022 Jul 26;12(1):12703. doi: 10.1038/s41598-022-16466-y.
- Results publication: PubMed 33001868Yang Y, Song C, Song C, Li C. Comparison of Bispectral Index-Guided Individualized Anesthesia with Standard General Anesthesia on Inadequate Emergence and Postoperative Delirium in Elderly Patients Undergoing Esophagectomy: A Retrospective Study at a Single Center. Med Sci Monit. 2020 Oct 1;26:e925314. doi: 10.12659/MSM.925314.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed EEG monitoring in people with Critically Ill Patients, run by Mahidol University at 1 site in Thailand.
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 6 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annop Piriyapatsom, M.D. (+66 2419 7990, annop.pir@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS value (time frame: 24 hours following inclusion). 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 NCT07583732, which also lists 16 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 13 May 2026.