Postoperative DeliriumNCT06542978
Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
A study testing 40Hz stimulation in people with Postoperative Delirium and Anesthesia, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Anesthesia, Elderly
- What is being tested?
- 40Hz stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Mar 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1.Age ≥ 65 years old,gender not limited
- 2.ASA classification Ⅱ ~ Ⅳ
- 3.Elective gastrointestinal general anesthesia surgery
Who cannot join
- 1.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
- 2.Pre-operative coma, severe dementia, speech impairment or severe illness incapacitated and unable to communicate
- 3.Delirium on admission or pre-operative delirium, brain injury
- 4.Severely infected person
- 5.Severe liver dysfunction (Child-Pugh C), severe renal insufficiency (preoperative dialysis)
- 6.Severe hearing or vision impairment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan People's Hospital
Zhengzhou, Henan
Zhang jiaqiang, 037165580728, hnmzxh@163.com
About this study
Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. It is one of the most common surgical complications in the elderly, occurring in more than 75% of patients receiving mechanical ventilation in the intensive care unit(ICU).Exogenous 40 Hz stimulation can improve cognitive functioning.Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing elective gastrointestinal surgery in AICU.
- Conditions
- Postoperative Delirium, Anesthesia, Elderly
- Being tested
- 40Hz stimulation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40Hz stimulationDevice
Exogenous 40HZ stimulation is a physical intervention that can drive oscillations in the gamma range, and the oscillations and pulses caused at the corresponding frequency can lead to a significant reduction in β-amyloid, reverse tau hyperphosphorylation, and thereby improve the cognitive function of patients.
| Study group | Role | What they receive |
|---|---|---|
| 40Hz stimulation group | Experimental | After admission to AICU, the experimental group was stimulated at 40Hz for 6h; Receives: Device: 40Hz stimulation |
| Control group | No intervention | After admission to AICU, the control group was not stimulated at 40Hz ; |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium
Postoperative delirium was assessed using the CAM-ICU scale.The RASS score (The Richmond Agitation-Sedation Scale) was used to assess arousal. When the patient's RASS score is not -4 /-5, delirium evaluation can continue considering the patient's wakefulness status.CAM-ICU scale contains four features (Feature 1, Feature 2, Feature 3, and Feature 4). Delirium can be diagnosed when the patient is positive for features 1, 2, 3, or 4.
Measured: Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery
Secondary outcomes (3)
Blood Markers
Serum Tau proteomic analysis and CRP, IL-6, and TNF-ɑ were recorded
Measured: half hour, 6hours, 24hours and 48hours after transfer to aicu
Sleep quality
The Chinese version of the Richards-Campbell Sleep Quality Scale Score (RCSQ) was used to evaluate sleep quality. RCSQ scoring average for five projects, including 0 ~ 25 points on behalf of the poor quality of sleep, on behalf of the sleep quality of 76 ~ 100 points; The higher the score says sleep quality, the better
Measured: 8:00 to 10:00 every morning for the first three days after surgery
The incidence of pain
Mark a 0-10cm horizontal line on the paper with a ruler, and determine the score in millimeters (mm). The score range is 0-100mm, and the higher the score, the greater the pain intensity; No pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), severe pain (75-100 mm).
Measured: 6hours, 24hours, 48hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 May 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542978
- Sponsor's protocol ID
- Henan FYX
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06542978
- Acronym / sponsor ID
- Henan FYX
- Conditions
- Postoperative Delirium, Anesthesia, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Aug 2024 (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.
Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. It is one of the most common surgical complications in the elderly, occurring in more than 75% of patients receiving mechanical ventilation in the intensive care unit(ICU).Exogenous 40 Hz stimulation can improve cognitive functioning.Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing elective gastrointestinal surgery in AICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40Hz stimulation group | Experimental | Device: 40Hz stimulationAfter admission to AICU, the experimental group was stimulated at 40Hz for 6h; |
| Control group | No intervention | –After admission to AICU, the control group was not stimulated at 40Hz ; |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 1.Age ≥ 65 years old,gender not limited
- 2.ASA classification Ⅱ ~ Ⅳ
- 3.Elective gastrointestinal general anesthesia surgery
Key exclusion criteria (6 listed)
- 1.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
- 2.Pre-operative coma, severe dementia, speech impairment or severe illness incapacitated and unable to communicate
- 3.Delirium on admission or pre-operative delirium, brain injury
- 4.Severely infected person
- 5.Severe liver dysfunction (Child-Pugh C), severe renal insufficiency (preoperative dialysis)
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 |
|---|---|---|
| 40Hz stimulationExogenous 40HZ stimulation is a physical intervention that can drive oscillations in the gamma range, and the oscillations and pulses caused at the corresponding frequency can lead to a significant reduction in β-amyloid, reverse tau hyperphosphorylation, and thereby improve the cognitive function of patients. | Device | 40Hz stimulation group |
Primary outcome
The incidence of postoperative delirium
Time frame: Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery
Postoperative delirium was assessed using the CAM-ICU scale.The RASS score (The Richmond Agitation-Sedation Scale) was used to assess arousal. When the patient's RASS score is not -4 /-5, delirium evaluation can continue considering the patient's wakefulness status.CAM-ICU scale contains four features (Feature 1, Feature 2, Feature 3, and Feature 4). Delirium can be diagnosed when the patient is positive for features 1, 2, 3, or 4.
3 secondary outcomes
Blood Markers
Time frame: half hour, 6hours, 24hours and 48hours after transfer to aicu
Sleep quality
Time frame: 8:00 to 10:00 every morning for the first three days after surgery
The incidence of pain
Time frame: 6hours, 24hours, 48hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40Hz stimulation in people with Postoperative Delirium and Anesthesia, run by Henan Provincial People's Hospital 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 28 Oct 2024. 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 Zhang jiaqiang (037165580728, hnmzxh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium (time frame: Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery). 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 28 Oct 2024.