AcupunctureNCT05535985
Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
A study testing acupuncture in people with Acupuncture and Postoperative Delirium (POD), run by Lingling Ding.
Trial summary
1. To evaluate the effectiveness and safety of acupuncture on POD in diabetic patients undergoing surgery, to provide effective prevention and treatment measures of integrated traditional Chinese and western medicine for reducing the incidence of postoperative delirium in high-risk groups, and to provide clinical… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acupuncture, Postoperative Delirium (POD), Diabetes Mellitus
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing general anesthesia in our hospital
- Expected duration of operation >2h
- Ages 18-60
- With type 2 diabetes
- American Society of Anesthesiologists (ASA) grade 2-3 , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
- Expected postoperative hospital stay >3 days
- No history of cerebrovascular accident in the past six months
- The informed consent signed
Who cannot join
- Unable or unwilling to cooperate with cognitive function scale tests
- MMSE score <24
- Refuse acupuncture treatment or have a history of needle sickness
- With skin damage at the acupuncture sites
- Coagulation dysfunction
- Participated in other clinical studies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Controlled Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
- To evaluate the effectiveness and safety of acupuncture on POD in diabetic patients undergoing surgery, to provide effective prevention and treatment measures of integrated traditional Chinese and western medicine for reducing the incidence of postoperative delirium in high-risk groups, and to provide clinical basis for further promotion of integrated traditional Chinese and western medicine anesthesia in the future.
- To investigate the relationship between POD and rSO2 in diabetic patients undergoing surgery. To clarify the predictive value of intraoperative rSO2 monitoring on postoperative cognitive function in patients with diabetes, and to explore the effect of acupuncture on cerebral blood flow perfusion in patients with diabetes.
Read the detailed description
Postoperative delirium (POD) increases the risk of postoperative dementia and mortality. Cognitive decline is common in patients with diabetes mellitus. As an independent risk factor for POD, diabetes significantly increases postoperative dementia and mortality. Our team found that acupuncture can reduce the incidence of POD in elderly patients, increase regional cerebral oxygen saturation (rSO2), and increase cerebral blood flow perfusion in diabetic patients. In this study, a prospective randomized controlled study with placebo acupuncture will be conducted. Diabetic patients undergoing elective surgery will be divided into acupuncture group, placebo acupuncture group and control group. Acupuncture will be used as the intervention method, and the incidence of POD will be the main therapeutic effect evaluation index to explore the efficacy of acupuncture in the prevention and treatment of POD in diabetic patients undergoing surgery.
- Conditions
- Acupuncture, Postoperative Delirium (POD), Diabetes Mellitus
- Being tested
- acupuncture, placebo acupuncture
- Keywords
- Acupuncture, Postoperative delirium (POD), Diabetes Mellitus, Regional Cerebral Oxygen Saturation (rSO2)
- Medical subject headings
- Emergence Delirium, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
treatment of pain or disease by inserting the tips of needles at specific points on the skin
placebo acupunctureDevice
placebo acupuncture
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | In the acupuncture group, acupoints of Baihui, Shenting, Sishencong will be selected for acupuncture stimulation be anesthesia. The needle will be kept for 30 minutes, during which the needle will be performed once every 10 minutes for 10 seconds each time, 4 times in total. The therapist will give the subject verbal cues before and during the needle manipulation. Receives: Device: acupuncture |
| placebo acupuncture group | Placebo comparator | The patients will be treated with consolation needle. Choose treatment of points that near but without going through the acupoints(upper arm deltoid muscle). Use the Park needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time and number of needles will be the same as those in the acupuncture group. The therapist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other. Receives: Device: placebo acupuncture |
| control group | No intervention | The patients will undergoing routine anesthesia without acupuncture treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
assess the incidence of postoperative delirium using the 3-minute diagnostic confusion assessment method (3D-CAM)
Measured: at 8 a.m. the day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Measured: at 16 p.m. the day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Measured: at 8 a.m. the second day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Measured: at 16 p.m. the second day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Measured: at 8 a.m. the third day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Measured: at 16 p.m. the third day after surgery
Secondary outcomes (10)
Regional Saturation of Oxygenation (rSO2)
The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes.
rSO2 values of each time point, maximum and minimum values during surgery.
Measured: baseline
Regional Saturation of Oxygenation (rSO2)
The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes.
rSO2 values of each time point, maximum and minimum values during surgery.
Measured: the time when tracheal intubation finished
Regional Saturation of Oxygenation (rSO2)
The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes.
rSO2 values of each time point, maximum and minimum values during surgery.
Measured: the time when the surgery begins
Regional Saturation of Oxygenation (rSO2)
The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes.
rSO2 values of each time point, maximum and minimum values during surgery.
Measured: 1 hour after the beginning of the surgery
Regional Saturation of Oxygenation (rSO2)
The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes.
rSO2 values of each time point, maximum and minimum values during surgery.
Measured: the time when the surgery ends
Regional Saturation of Oxygenation (rSO2)
The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes.
rSO2 values of each time point, maximum and minimum values during surgery.
Measured: Intraoperative
Visual Analogue Score (VAS)
Record VAS. VAS is a psychometric response score. Draw a 10 cm horizontal line on the paper. The end of the line is 0, indicating no pain; the other end is 10, indicating severe pain. The middle part shows different levels of pain.
Measured: at 8 a.m. and 16 p.m. daily for 3 days after surgery
Blood glucose levels
record blood glucose levels
Measured: Entering the operating room, the time when the surgery ends
Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum
The inflammation level will be assessed.
Measured: Entering the operating room, the time when the surgery ends
Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α)
assess the expression of PGC-1α
Measured: Entering the operating room, the time when the surgery ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingling Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lingling Ding, Beijing Hospital of Traditional Chinese Medicine
- Investigators
- Lingling Ding, Doctor, Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535985
- Sponsor's protocol ID
- SHOUFA 2022-2-2232
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 14 Sep 2022
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05535985
- Acronym / sponsor ID
- SHOUFA 2022-2-2232
- Conditions
- Acupuncture, Postoperative Delirium (POD), Diabetes Mellitus
- Keywords
- Acupuncture, Postoperative delirium (POD), Diabetes Mellitus, Regional Cerebral Oxygen Saturation (rSO2)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Lingling DingUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Sep 2022 (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.
- To evaluate the effectiveness and safety of acupuncture on POD in diabetic patients undergoing surgery, to provide effective prevention and treatment measures of integrated traditional Chinese and western medicine for reducing the incidence of postoperative delirium in high-risk groups, and to provide clinical basis for further promotion of integrated traditional Chinese and western medicine anesthesia in the future.
- To investigate the relationship between POD and rSO2 in diabetic patients undergoing surgery. To clarify the predictive value of intraoperative rSO2 monitoring on postoperative cognitive function in patients with diabetes, and to explore the effect of acupuncture on cerebral blood flow perfusion in patients with diabetes.
Detailed description
Postoperative delirium (POD) increases the risk of postoperative dementia and mortality. Cognitive decline is common in patients with diabetes mellitus. As an independent risk factor for POD, diabetes significantly increases postoperative dementia and mortality. Our team found that acupuncture can reduce the incidence of POD in elderly patients, increase regional cerebral oxygen saturation (rSO2), and increase cerebral blood flow perfusion in diabetic patients. In this study, a prospective randomized controlled study with placebo acupuncture will be conducted. Diabetic patients undergoing elective surgery will be divided into acupuncture group, placebo acupuncture group and control group. Acupuncture will be used as the intervention method, and the incidence of POD will be the main therapeutic effect evaluation index to explore the efficacy of acupuncture in the prevention and treatment of POD in diabetic patients undergoing surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Device: acupunctureIn the acupuncture group, acupoints of Baihui, Shenting, Sishencong will be selected for acupuncture stimulation be anesthesia. The needle will be kept for 30 minutes, during which the needle will be performed once every 10 minutes for 10 seconds each time, 4 times in total. The therapist will give the subject verbal cues before and during the needle manipulation. |
| placebo acupuncture group | Placebo comparator | Device: placebo acupunctureThe patients will be treated with consolation needle. Choose treatment of points that near but without going through the acupoints(upper arm deltoid muscle). Use the Park needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time and number of needles will be the same as those in the acupuncture group. The therapist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other. |
| control group | No intervention | –The patients will undergoing routine anesthesia without acupuncture treatment. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing general anesthesia in our hospital
- Expected duration of operation >2h
- Ages 18-60
- With type 2 diabetes
- American Society of Anesthesiologists (ASA) grade 2-3 , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
Key exclusion criteria (6 listed)
- Unable or unwilling to cooperate with cognitive function scale tests
- MMSE score <24
- Refuse acupuncture treatment or have a history of needle sickness
- With skin damage at the acupuncture sites
- Coagulation dysfunction
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 |
|---|---|---|
| acupuncturetreatment of pain or disease by inserting the tips of needles at specific points on the skin | Device | acupuncture group |
| placebo acupunctureplacebo acupuncture | Device | placebo acupuncture group |
Primary outcome
Incidence of postoperative delirium
Time frame: at 8 a.m. the day after surgery
assess the incidence of postoperative delirium using the 3-minute diagnostic confusion assessment method (3D-CAM)
Incidence of postoperative delirium
Time frame: at 16 p.m. the day after surgery
assess the incidence of postoperative delirium using 3D-CAM
Incidence of postoperative delirium
Time frame: at 8 a.m. the second day after surgery
assess the incidence of postoperative delirium using 3D-CAM
Incidence of postoperative delirium
Time frame: at 16 p.m. the second day after surgery
assess the incidence of postoperative delirium using 3D-CAM
Incidence of postoperative delirium
Time frame: at 8 a.m. the third day after surgery
assess the incidence of postoperative delirium using 3D-CAM
Incidence of postoperative delirium
Time frame: at 16 p.m. the third day after surgery
assess the incidence of postoperative delirium using 3D-CAM
10 secondary outcomes
Regional Saturation of Oxygenation (rSO2)
Time frame: baseline
Regional Saturation of Oxygenation (rSO2)
Time frame: the time when tracheal intubation finished
Regional Saturation of Oxygenation (rSO2)
Time frame: the time when the surgery begins
Regional Saturation of Oxygenation (rSO2)
Time frame: 1 hour after the beginning of the surgery
Regional Saturation of Oxygenation (rSO2)
Time frame: the time when the surgery ends
Regional Saturation of Oxygenation (rSO2)
Time frame: Intraoperative
Visual Analogue Score (VAS)
Time frame: at 8 a.m. and 16 p.m. daily for 3 days after surgery
Blood glucose levels
Time frame: Entering the operating room, the time when the surgery ends
Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum
Time frame: Entering the operating room, the time when the surgery ends
Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α)
Time frame: Entering the operating room, the time when the surgery ends
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- 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.
Lingling Ding, Doctor principal investigator
Beijing Hospital of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Acupuncture and Postoperative Delirium (POD), run by Lingling Ding.
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 8 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingling Ding, Doctor (+86 010 87906647, dinglingling301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: at 8 a.m. the day after surgery). The study lists 6 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 14 Sep 2022.