Delirium in Old AgeNCT05694091
Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients
An observational study of Delirium in Old Age, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
In view of the increasingly severe aging situation in China, the perioperative brain health of elderly patients has received increasing attention. Postoperative delirium (POD) is a common postoperative complication characterized by acute consciousness and cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sample
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2022to 31 Dec 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients 65-90 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and delirium scales were evaluated.
Who may be able to join
- The ASA grade of the subject is Ⅰ - Ⅲ;
- 65-90 years old;
- Oral craniomaxillofacial surgery under combined general anesthesia
Who cannot join
- The following medical devices have been installed in the body or are to be installed or implanted in the hospital: various cardiac pacemakers; Metal implants (non titanium), ferromagnetic vascular clips in the body
- The patient is left-handed;
- Patients with claustrophobia;
- People with vision and hearing impairment, illiterate or difficult to communicate;
- The operation plan includes patients with tracheotomy or postoperative catheterization;
- Refusing to sign the clinical trial consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 9Th Hospital
Shanghai, Shanghai Municipality, 200000
Hong Jiang, jianghongjiuyuan@163.com
About this study
In view of the increasingly severe aging situation in China, the perioperative brain health of elderly patients has received increasing attention. Postoperative delirium (POD) is a common postoperative complication characterized by acute consciousness and cognitive dysfunction. The incidence of POD in elderly patients undergoing elective non cardiac surgery is 20%~45%, which often indicates poor cognitive recovery and becomes a heavy burden for family and society. Although the weight of human brain only accounts for 2% of body weight, the oxygen consumption accounts for 20% of the total oxygen consumption of the whole body. On July 2, 2022, the British Journal of Anaesthesia (Chinese Academy of Sciences Division 1, Anesthesiology Division 1, IF11.719), the top international Journal in the field of anesthesiology, published the scientific research achievements of the first author of the applicant. It was found for the first time that sevoflurane, the most commonly used inhalation anesthetic in clinical practice, can cause the activation of glycolysis and the increase of lactic acid in the brain of elderly non-human primate marmosets, which suggests that general anesthetics will affect brain metabolism in the perioperative period. Therefore, we hypothesized that perioperative changes in brain metabolism might be related to the occurrence of POD in elderly patients. The purpose of this study was to study the relationship between the changes of brain metabolites and POD during perioperative period by noninvasive monitoring of the characteristics of brain tissue metabolites 24 hours before and 24 hours after the operation with hydrogen ion proton magnetic resonance spectroscopy (1-HMRS). In order to complete this purpose, this study plans to collect subjects aged 65~90 years who are scheduled to undergo oral and maxillofacial surgery under general anesthesia. The changes of brain metabolites before and after operation were collected by 1-HMRS, and the postoperative delirium related scale was evaluated to analyze the relationship between perioperative changes of brain metabolites and POD.
- Conditions
- Delirium in Old Age
- Being tested
- Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sampleOther
Collecting clinical data(before induction of anesthesia and first day after surgery), blood gas data(before induction of anesthesia and first day after surgery) ，MRS data (not more than 24h after surgery）and blood,urine, and feces sample （before induction of anesthesia and first day, third day and 7th day after surgery）
| Study group | Role | What they receive |
|---|---|---|
| Patients in the control group were followed up without delirium postoperatively. | If the 3D-CAM scale all show a negative resluts Receives: Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sample | |
| Patients in the case group were followed up with delirium postoperatively. | If the 3D-CAM assessment is positive at any time point after surgery Receives: Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
3D-CAM higher means worse
Measured: 1 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
3D-CAM higher means worse
Measured: 2 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
3D-CAM higher means worse
Measured: 3 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
3D-CAM higher means worse
Measured: 4 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
3D-CAM higher means worse
Measured: 5 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
3D-CAM higher means worse
Measured: 6 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
3D-CAM higher means worse
Measured: 7 day after surgery
Secondary outcomes (6)
MOCA(Montreal Cognitive Assessment) scale
MOCA higher means better
Measured: 1 day after surgery
MOCA(Montreal Cognitive Assessment) scale
MOCA higher means better
Measured: 3 day after surgery
MOCA(Montreal Cognitive Assessment) scale
MOCA higher means better
Measured: 7 day after surgery
MMSE (mini-mental state examiniation) scale
MMSE higher means better
Measured: 1 day after surgery
MMSE (mini-mental state examiniation) scale
MMSE higher means better
Measured: 3 day after surgery
MMSE (mini-mental state examiniation) scale
MMSE higher means better
Measured: 7 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 posted23 Jan 2023
- Study start18 Nov 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Jiang, Doctor, Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694091
- Sponsor's protocol ID
- SH9H-2022-T331-1
- Status last verified
- Nov 2022
- First submitted
- 12 Jan 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients
- ClinicalTrials.gov ID
- NCT05694091
- Acronym / sponsor ID
- SH9H-2022-T331-1
- Conditions
- Delirium in Old Age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 2023 (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.
In view of the increasingly severe aging situation in China, the perioperative brain health of elderly patients has received increasing attention. Postoperative delirium (POD) is a common postoperative complication characterized by acute consciousness and cognitive dysfunction. The incidence of POD in elderly patients undergoing elective non cardiac surgery is 20%~45%, which often indicates poor cognitive recovery and becomes a heavy burden for family and society. Although the weight of human brain only accounts for 2% of body weight, the oxygen consumption accounts for 20% of the total oxygen consumption of the whole body. On July 2, 2022, the British Journal of Anaesthesia (Chinese Academy of Sciences Division 1, Anesthesiology Division 1, IF11.719), the top international Journal in the field of anesthesiology, published the scientific research achievements of the first author of the applicant. It was found for the first time that sevoflurane, the most commonly used inhalation anesthetic in clinical practice, can cause the activation of glycolysis and the increase of lactic acid in the brain of elderly non-human primate marmosets, which suggests that general anesthetics will affect brain metabolism in the perioperative period. Therefore, we hypothesized that perioperative changes in brain metabolism might be related to the occurrence of POD in elderly patients. The purpose of this study was to study the relationship between the changes of brain metabolites and POD during perioperative period by noninvasive monitoring of the characteristics of brain tissue metabolites 24 hours before and 24 hours after the operation with hydrogen ion proton magnetic resonance spectroscopy (1-HMRS). In order to complete this purpose, this study plans to collect subjects aged 65~90 years who are scheduled to undergo oral and maxillofacial surgery under general anesthesia. The changes of brain metabolites before and after operation were collected by 1-HMRS, and the postoperative delirium related scale was evaluated to analyze the relationship between perioperative changes of brain metabolites and POD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in the control group were followed up without delirium postoperatively. | – | Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sampleIf the 3D-CAM scale all show a negative resluts |
| Patients in the case group were followed up with delirium postoperatively. | – | Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sampleIf the 3D-CAM assessment is positive at any time point after surgery |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients 65-90 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and delirium scales were evaluated.
Key inclusion criteria (3 listed)
- The ASA grade of the subject is Ⅰ - Ⅲ;
- 65-90 years old;
- Oral craniomaxillofacial surgery under combined general anesthesia
Key exclusion criteria (6 listed)
- The following medical devices have been installed in the body or are to be installed or implanted in the hospital: various cardiac pacemakers; Metal implants (non titanium), ferromagnetic vascular clips in the body
- The patient is left-handed;
- Patients with claustrophobia;
- People with vision and hearing impairment, illiterate or difficult to communicate;
- The operation plan includes patients with tracheotomy or postoperative catheterization;
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 |
|---|---|---|
| Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sampleCollecting clinical data(before induction of anesthesia and first day after surgery), blood gas data(before induction of anesthesia and first day after surgery) ，MRS data (not more than 24h after surgery）and blood,urine, and feces sample （before induction of anesthesia and first day, third day and 7th day after surgery） | Other | Patients in the case group were followed up with delirium postoperatively., Patients in the control group were followed up without delirium postoperatively. |
Primary outcome
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
Time frame: 1 day after surgery
3D-CAM higher means worse
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
Time frame: 2 day after surgery
3D-CAM higher means worse
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
Time frame: 3 day after surgery
3D-CAM higher means worse
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
Time frame: 4 day after surgery
3D-CAM higher means worse
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
Time frame: 5 day after surgery
3D-CAM higher means worse
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
Time frame: 6 day after surgery
3D-CAM higher means worse
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
Time frame: 7 day after surgery
3D-CAM higher means worse
6 secondary outcomes
MOCA(Montreal Cognitive Assessment) scale
Time frame: 1 day after surgery
MOCA(Montreal Cognitive Assessment) scale
Time frame: 3 day after surgery
MOCA(Montreal Cognitive Assessment) scale
Time frame: 7 day after surgery
MMSE (mini-mental state examiniation) scale
Time frame: 1 day after surgery
MMSE (mini-mental state examiniation) scale
Time frame: 3 day after surgery
MMSE (mini-mental state examiniation) scale
Time frame: 7 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Hong Jiang, Doctor study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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 Delirium in Old Age, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 3 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: status not confirmed, as of the sponsor's last update on 6 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ren Zhou, PhD (15121007303, zhouren77@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale (time frame: 1 day after surgery). The study lists 7 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 6 Jul 2023.