Postoperative DeliriumNCT04292561
Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia
A study testing Low MAC and High MAC in people with Postoperative Delirium and Sevoflurane, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG) suppression during operation is related to postoperative delirium. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Postoperative Delirium, Sevoflurane, Electroencephalogram
- What is being tested?
- Low MAC and High MAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 10 Feb 2023
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of gastrointestinal diseases
- Patients were aged 60 to 90 years
- American Society of Anesthesiologists (ASA) risk classification II-IV
- Patients were scheduled to undergo elective major abdominal operation(with a anticipated time of 2-6 h)
Who cannot join
- Preoperative dementia or cognitive impairment
- Mental instability or mental illness
- Patients with any factors affecting cognitive assessment, such as language, vision and hearing impairment
- Any cerebrovascular accident occurred within 3 months, such as stroke etc
- Previous history of delirium
- Known hypersensitivity to sevoflurane or history of malignant hyperthermia
- Abuse of narcotic sedative and analgesic drugs
- Those who have reoperation within 7 days after operation
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
About this study
Official title: Effects of Different Sevoflurane Concentrations on Intraoperative EEG and Postoperative Delirium in Elderly Patients
Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG) suppression during operation is related to postoperative delirium. The latest research shows that the anesthesia depth guided by EEG does not reduce the incidence of postoperative delirium. The purpose of this study was to explore the relationship between anesthesia exposure with different minimum alveolar concentration(MAC) and postoperative delirium(POD), and to observe the characteristics of EEG.
Read the detailed description
More and more studies have focused on the relationship between EEG inhibition and postoperative delirium in general anesthesia. At present, there are two kinds of commonly processed quantitative EEG monitoring to evaluate the depth of anesthesia, one is bispectral index (BIS) and the other is patient state index (PSI). The relationship between intraoperative anesthetic exposure and postoperative delirium is unclear, or whether potential patient characteristics increase the risk of EEG suppression and postoperative delirium.
Gastrointestinal surgery can lead to long-term changes in colonic flora, which can remotely regulate brain function through the gut brain axis. We speculated that the abnormal composition of intestinal flora before abdominal operation might be the influencing factor of POD.
- Conditions
- Postoperative Delirium, Sevoflurane, Electroencephalogram
- Being tested
- Low MAC, High MAC
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low MACDrug
To maintain a target of sevoflurane inhalation concentration 0.8 MAC.
High MACDrug
To maintain a target of sevoflurane inhalation concentration 1.0 MAC.
| Study group | Role | What they receive |
|---|---|---|
| light general anesthesia | Experimental | During anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC. Receives: Drug: Low MAC |
| deep general anesthesia | Experimental | During anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC. Receives: Drug: High MAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POD
Incidence of POD after surgery
Measured: The 1st day after the surgery
Incidence of POD
Incidence of POD after surgery
Measured: The 2nd day after the surgery
Incidence of POD
Incidence of POD after surgery
Measured: The 3rd day after the surgery
Incidence of POD
Incidence of POD after surgery
Measured: The 5th day after the surgery
Incidence of POD
Incidence of POD after surgery
Measured: The 7th day after the surgery
Secondary outcomes (5)
EEG burst inhibition
Frequency of EEG burst inhibition
Measured: During surgery
EEG burst inhibition
Duration of EEG burst inhibition
Measured: During surgery
Incidence of adverse events
Incidence of adverse events after surgery
Measured: 30-day after surgery
length of stay
length of stay after surgery
Measured: From 1st day after the surgery to 2 weeks
30-day mortality
30-day mortality after surgery
Measured: 30-day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Mar 2020
- Primary completion30 Jan 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuesheng Liu, MD.PHD, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292561
- Sponsor's protocol ID
- 201912
- Status last verified
- Mar 2022
- First submitted
- 8 Jan 2020
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chaput AJ, Bryson GL. Postoperative delirium: risk factors and management: continuing professional development. Can J Anaesth. 2012 Mar;59(3):304-20. doi: 10.1007/s12630-011-9658-4. Epub 2012 Feb 4. English, French.
PubMed 22311257Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
PubMed 23027226Fritz 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 26418126Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
PubMed 30721296Ridaura V, Belkaid Y. Gut microbiota: the link to your second brain. Cell. 2015 Apr 9;161(2):193-4. doi: 10.1016/j.cell.2015.03.033.
PubMed 25860600
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Sevoflurane Concentrations on Intraoperative EEG and Postoperative Delirium in Elderly Patients
- ClinicalTrials.gov ID
- NCT04292561
- Acronym / sponsor ID
- 201912
- Conditions
- Postoperative Delirium, Sevoflurane, Electroencephalogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 3 Mar 2020 (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.
Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG) suppression during operation is related to postoperative delirium. The latest research shows that the anesthesia depth guided by EEG does not reduce the incidence of postoperative delirium. The purpose of this study was to explore the relationship between anesthesia exposure with different minimum alveolar concentration(MAC) and postoperative delirium(POD), and to observe the characteristics of EEG.
Detailed description
More and more studies have focused on the relationship between EEG inhibition and postoperative delirium in general anesthesia. At present, there are two kinds of commonly processed quantitative EEG monitoring to evaluate the depth of anesthesia, one is bispectral index (BIS) and the other is patient state index (PSI). The relationship between intraoperative anesthetic exposure and postoperative delirium is unclear, or whether potential patient characteristics increase the risk of EEG suppression and postoperative delirium.
Gastrointestinal surgery can lead to long-term changes in colonic flora, which can remotely regulate brain function through the gut brain axis. We speculated that the abnormal composition of intestinal flora before abdominal operation might be the influencing factor of POD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| light general anesthesia | Experimental | Drug: Low MACDuring anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC. |
| deep general anesthesia | Experimental | Drug: High MACDuring anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of gastrointestinal diseases
- Patients were aged 60 to 90 years
- American Society of Anesthesiologists (ASA) risk classification II-IV
- Patients were scheduled to undergo elective major abdominal operation(with a anticipated time of 2-6 h)
Key exclusion criteria (8 listed)
- Preoperative dementia or cognitive impairment
- Mental instability or mental illness
- Patients with any factors affecting cognitive assessment, such as language, vision and hearing impairment
- Any cerebrovascular accident occurred within 3 months, such as stroke etc
- Previous history of delirium
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 |
|---|---|---|
| Low MACTo maintain a target of sevoflurane inhalation concentration 0.8 MAC. | Drug | light general anesthesia |
| High MACTo maintain a target of sevoflurane inhalation concentration 1.0 MAC. | Drug | deep general anesthesia |
Primary outcome
Incidence of POD
Time frame: The 1st day after the surgery
Incidence of POD after surgery
Incidence of POD
Time frame: The 2nd day after the surgery
Incidence of POD after surgery
Incidence of POD
Time frame: The 3rd day after the surgery
Incidence of POD after surgery
Incidence of POD
Time frame: The 5th day after the surgery
Incidence of POD after surgery
Incidence of POD
Time frame: The 7th day after the surgery
Incidence of POD after surgery
5 secondary outcomes
EEG burst inhibition
Time frame: During surgery
EEG burst inhibition
Time frame: During surgery
Incidence of adverse events
Time frame: 30-day after surgery
length of stay
Time frame: From 1st day after the surgery to 2 weeks
30-day mortality
Time frame: 30-day after surgery
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 24 Feb 2023.
- Background: PubMed 22311257Chaput AJ, Bryson GL. Postoperative delirium: risk factors and management: continuing professional development. Can J Anaesth. 2012 Mar;59(3):304-20. doi: 10.1007/s12630-011-9658-4. Epub 2012 Feb 4. English, French.
- Background: PubMed 23027226Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
- 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 30721296Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
- Background: PubMed 25860600Ridaura V, Belkaid Y. Gut microbiota: the link to your second brain. Cell. 2015 Apr 9;161(2):193-4. doi: 10.1016/j.cell.2015.03.033.
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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.
Xuesheng Liu, MD.PHD principal investigator
The First Affiliated Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low MAC and High MAC in people with Postoperative Delirium and Sevoflurane, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
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 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 24 Feb 2023. 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 China. 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?
Incidence of POD (time frame: The 1st day after the surgery). The study lists 5 primary outcomes in all. 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 NCT04292561, which also lists 5 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 24 Feb 2023.