AcupunctureNCT05159674
Study on the Difference and Cause of Acupuncture Dexmedetomidine Compound Anesthesia Effect
A study testing Dexmedetomidine+electroacupuncture compound anesthesia in people with Acupuncture and Dexmedetomidine, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial summary
Studies have shown that the use of dexmedetomidine before and during surgery has a good sedative, analgesic and circulatory stabilizing effect. The use of dexmedetomidine in thoracoscopic lung resection has been proven to be safe and feasible, and it has a certain degree of improvement in postoperative lung function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acupuncture, Dexmedetomidine, Anesthesia
- What is being tested?
- Dexmedetomidine+electroacupuncture compound anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2021to 15 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pulmonary nodules scheduled for thoracoscopic surgery;
- Age ≥ 18 and ≤ 75, regardless of gender;
- Understand and agree to participate in this study and sign the informed consent form.
Who cannot join
- Patients who have previously received EA treatment;
- Patients with skin infection at acupoints;
- Patients with nerve injury of upper or lower limbs;
- Those who have participated or are participating in other clinical trials one month before enrollment.
About this study
Studies have shown that the use of dexmedetomidine before and during surgery has a good sedative, analgesic and circulatory stabilizing effect. The use of dexmedetomidine in thoracoscopic lung resection has been proven to be safe and feasible, and it has a certain degree of improvement in postoperative lung function. Combining the advantages of thoracoscopy and the previous experience of combined acupuncture and drug anesthesia technology, our team pioneered cardiopulmonary surgery without endotracheal intubation and combined needle and drug anesthesia, so that the patient was in a state of light sleep and spontaneous breathing without tracheal intubation. After completing the operation, it was found that this technical method can effectively reduce the amount of intraoperative anesthetics, improve intraoperative lung ventilation, improve lung oxygenation, achieve intraoperative organ protection, and significantly reduce complications caused by tracheal intubation , Postoperative analgesic drugs have reduced the amount of 20%, accelerate the time of exhaust and defecation, and its postoperative rehabilitation is better than conventional treatment. These results suggest that the combination of acupuncture and medicine is not only suitable for anesthesia, it can be used scientifically and rationally in postoperative analgesia, immune regulation and even the entire perioperative organ protection, creating more possibilities for patients' ERAS.
In combined acupuncture and drug anesthesia, the core goal is to use acupuncture to reduce the insufficiency of anesthetics in terms of analgesia, sedation, stable circulation, and protection of organs. However, the mechanism of action behind this type of combination has not yet been improved. Efficacy kinetics or pharmacokinetics has been explained convincingly, or it is not well recognized. For example, is there a specific target in the body of acupuncture? If there is a specific target, where is the effect target? If the combined application of acupuncture and medicine produces a synergistic effect through a pharmacokinetic mechanism, its specific mechanism still needs to be clarified.
Read the detailed description
Usually in a disease state, the body is in a state of strong stress, and the body's redox balance is disrupted. This state will also affect the activity of metabolic enzymes in the body, which in turn will have a corresponding impact on drug metabolism. Therefore, the body's basic redox level The monitoring of the drug is very important for the clinical development of individualized dosing regimens and the combined acupuncture and drug anesthesia mechanism.
Modern pharmacokinetic studies have shown that 90% of drugs (including most anesthetics) will undergo the metabolism of CYP enzyme and UGT enzyme, that is, their substrates. These drugs are mostly used in combination of multiple drugs in clinical practice. Therefore, it is not only necessary to study the individual change law of its single drug use, but also the change law of its multi-drug sharing and mutual influence. The original intention of sharing or combining drugs is to be beneficial to the patient, but when the common interaction between the shared drug and the original drug has a harmful effect on the body, adverse drug reactions will occur, which is also called drug-drug interaction (Drug-Drug Interaction DDI), and the production of DDI is nothing more than pharmacodynamics or pharmacokinetic interactions. Therefore, when combining drugs or combined acupuncture and drug anesthesia, it is also necessary to monitor the effects and effects of metabolic enzymes in the body on the drugs first, and then to determine the safety and the mechanism of the effect of multi-drug sharing.
It has been reported that the combination of acupuncture and medicine produces pharmacodynamic effects such as increased endorphins, reduction of stress, immune function regulation, and up-regulation of endorphin receptor activity. Therefore, this study will start from these aspects. To design research on the mechanism of combined acupuncture and drug anesthesia, we hope to observe objective evidence of pharmacokinetics or pharmacodynamics that significantly reduces the use of anesthetics.
- Conditions
- Acupuncture, Dexmedetomidine, Anesthesia
- Being tested
- Dexmedetomidine+electroacupuncture compound anesthesia
- Keywords
- Acupuncture, Dexmedetomidine, Combined anesthesia, Metabolic enzyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine+electroacupuncture compound anesthesiaDevice
Dexmedetomidine and acupuncture were given together to induce anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine+electroacupuncture compound anesthesia | Experimental | EA was given every day three days before surgery, 30 minutes before induction of anesthesia + the whole course of surgery, and every 12 hours from the first day after surgery, each treatment was performed for 30 minutes until 48 hours after surgery. During the operation, only dexmedetomidine was used to make BIS<80. Receives: Device: Dexmedetomidine+electroacupuncture compound anesthesia |
| Dexmedetomidine anesthesia | No intervention | There was no EA treatment before, during or after operation. During the operation, only dexmedetomidine was used to make BIS<80. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for bispectral index of EEG to be less than 80
The time required for bispectral index of EEG in the intervention group was lower than that in the non intervention group
Measured: From the time anesthesia was given until the end time of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Dec 2023 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159674
- Sponsor's protocol ID
- 2021.11.30
- Status last verified
- Nov 2021
- First submitted
- 30 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Difference and Cause of Acupuncture Dexmedetomidine Compound Anesthesia Effect
- ClinicalTrials.gov ID
- NCT05159674
- Acronym / sponsor ID
- 2021.11.30
- Conditions
- Acupuncture, Dexmedetomidine, Anesthesia
- Keywords
- Acupuncture, Dexmedetomidine, Combined anesthesia, Metabolic enzyme
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 16 Dec 2021 (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.
Studies have shown that the use of dexmedetomidine before and during surgery has a good sedative, analgesic and circulatory stabilizing effect. The use of dexmedetomidine in thoracoscopic lung resection has been proven to be safe and feasible, and it has a certain degree of improvement in postoperative lung function. Combining the advantages of thoracoscopy and the previous experience of combined acupuncture and drug anesthesia technology, our team pioneered cardiopulmonary surgery without endotracheal intubation and combined needle and drug anesthesia, so that the patient was in a state of light sleep and spontaneous breathing without tracheal intubation. After completing the operation, it was found that this technical method can effectively reduce the amount of intraoperative anesthetics, improve intraoperative lung ventilation, improve lung oxygenation, achieve intraoperative organ protection, and significantly reduce complications caused by tracheal intubation , Postoperative analgesic drugs have reduced the amount of 20%, accelerate the time of exhaust and defecation, and its postoperative rehabilitation is better than conventional treatment. These results suggest that the combination of acupuncture and medicine is not only suitable for anesthesia, it can be used scientifically and rationally in postoperative analgesia, immune regulation and even the entire perioperative organ protection, creating more possibilities for patients' ERAS.
In combined acupuncture and drug anesthesia, the core goal is to use acupuncture to reduce the insufficiency of anesthetics in terms of analgesia, sedation, stable circulation, and protection of organs. However, the mechanism of action behind this type of combination has not yet been improved. Efficacy kinetics or pharmacokinetics has been explained convincingly, or it is not well recognized. For example, is there a specific target in the body of acupuncture? If there is a specific target, where is the effect target? If the combined application of acupuncture and medicine produces a synergistic effect through a pharmacokinetic mechanism, its specific mechanism still needs to be clarified.
Detailed description
Usually in a disease state, the body is in a state of strong stress, and the body's redox balance is disrupted. This state will also affect the activity of metabolic enzymes in the body, which in turn will have a corresponding impact on drug metabolism. Therefore, the body's basic redox level The monitoring of the drug is very important for the clinical development of individualized dosing regimens and the combined acupuncture and drug anesthesia mechanism.
Modern pharmacokinetic studies have shown that 90% of drugs (including most anesthetics) will undergo the metabolism of CYP enzyme and UGT enzyme, that is, their substrates. These drugs are mostly used in combination of multiple drugs in clinical practice. Therefore, it is not only necessary to study the individual change law of its single drug use, but also the change law of its multi-drug sharing and mutual influence. The original intention of sharing or combining drugs is to be beneficial to the patient, but when the common interaction between the shared drug and the original drug has a harmful effect on the body, adverse drug reactions will occur, which is also called drug-drug interaction (Drug-Drug Interaction DDI), and the production of DDI is nothing more than pharmacodynamics or pharmacokinetic interactions. Therefore, when combining drugs or combined acupuncture and drug anesthesia, it is also necessary to monitor the effects and effects of metabolic enzymes in the body on the drugs first, and then to determine the safety and the mechanism of the effect of multi-drug sharing.
It has been reported that the combination of acupuncture and medicine produces pharmacodynamic effects such as increased endorphins, reduction of stress, immune function regulation, and up-regulation of endorphin receptor activity. Therefore, this study will start from these aspects. To design research on the mechanism of combined acupuncture and drug anesthesia, we hope to observe objective evidence of pharmacokinetics or pharmacodynamics that significantly reduces the use of anesthetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine+electroacupuncture compound anesthesia | Experimental | Device: Dexmedetomidine+electroacupuncture compound anesthesiaEA was given every day three days before surgery, 30 minutes before induction of anesthesia + the whole course of surgery, and every 12 hours from the first day after surgery, each treatment was performed for 30 minutes until 48 hours after surgery. During the operation, only dexmedetomidine was used to make BIS<80. |
| Dexmedetomidine anesthesia | No intervention | –There was no EA treatment before, during or after operation. During the operation, only dexmedetomidine was used to make BIS<80. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pulmonary nodules scheduled for thoracoscopic surgery;
- Age ≥ 18 and ≤ 75, regardless of gender;
- Understand and agree to participate in this study and sign the informed consent form.
Key exclusion criteria (4 listed)
- Patients who have previously received EA treatment;
- Patients with skin infection at acupoints;
- Patients with nerve injury of upper or lower limbs;
- Those who have participated or are participating in other clinical trials one month before enrollment.
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 |
|---|---|---|
| Dexmedetomidine+electroacupuncture compound anesthesiaDexmedetomidine and acupuncture were given together to induce anesthesia | Device | Dexmedetomidine+electroacupuncture compound anesthesia |
Primary outcome
Time required for bispectral index of EEG to be less than 80
Time frame: From the time anesthesia was given until the end time of the surgery
The time required for bispectral index of EEG in the intervention group was lower than that in the non intervention group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine+electroacupuncture compound anesthesia in people with Acupuncture and Dexmedetomidine, run by Shanghai Yueyang Integrated Medicine Hospital.
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 4 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 16 Dec 2021. 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. 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?
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?
Time required for bispectral index of EEG to be less than 80 (time frame: From the time anesthesia was given until the end time of the 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 16 Dec 2021.