AnesthesiaNCT05716399
Effect of Acupoint Electrical Stimulation on Incidence of Hypotension After Spinal Anesthesia
A study testing Transcutaneous electric stimulation pretreatment, Transcutaneous acupoint electrical stimulation treatment and Transcutaneous acupoint pseudo electric stimulation in people with Anesthesia, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
Trial summary
This study is intended to include elderly patients who are selected to undergo lower limb and pelvic orthopedic surgery under spinal anesthesia. Through prospective, randomized and controlled clinical trials, the investigators will observe the effect of this treatment on the incidence of hypotension in elderly… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Transcutaneous electric stimulation pretreatment, Transcutaneous acupoint electrical stimulation treatment and Transcutaneous acupoint pseudo electric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 30 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 90>65, regardless of gender;
- ASA classification I-III; ③ Orthopedic surgery was performed under spinal anesthesia; ④ Sign the informed consent form.
Who cannot join
- Uncontrolled hypertension;
- Arrhythmia or myocardial ischemia;
- Severe cardiopulmonary insufficiency;
- HB<100g/L;
- Severe dehydration; ⑥ There are contraindications to spinal anesthesia; ⑦ Allergies to local anesthetics;
- Communication barriers; ⑨ Refusing to sign the informed consent form.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Transcutaneous Electrical Stimulation of Acupoints on the Incidence of Hypotension After Spinal Anesthesia in Elderly Patients Undergoing Orthopaedic Surgery
This study is intended to include elderly patients who are selected to undergo lower limb and pelvic orthopedic surgery under spinal anesthesia. Through prospective, randomized and controlled clinical trials, the investigators will observe the effect of this treatment on the incidence of hypotension in elderly patients after spinal anesthesia through TEAS points Neiguan and Quchi before or during surgery, and further explore its related mechanisms.
Read the detailed description
Research content: This study aims to observe whether TEAS intervention on Neiguan (PC-6) and Quchi (LI-11) before and during operation can improve the incidence and degree of hypotension after spinal anesthesia, as well as the changes of neurotransmitters and related hormones in blood.
Research methods:
- 111 elderly patients (including hip or lower limb fractures, hip and knee joint replacement or debridement) who were selected for lower limb or pelvic surgery under spinal anesthesia were randomly divided into percutaneous point electrical stimulation pretreatment group (PTEAS group), percutaneous point electrical stimulation treatment group (TEAS group) and percutaneous point pseudo electrical stimulation group (FTEAS group).
- After entering the operating room, the vital signs were monitored routinely, and the volume was evaluated by measuring the variability of the inferior vena cava with ultrasound before anesthesia. Then, the radial artery was punctured and catheterized, and sodium lactate was infused (8ml/Kg).
- Within 30 minutes before spinal anesthesia or 30 minutes after hypotension, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points, and the current intensity was only as high as the patient could comfortably tolerate (the electrical stimulation intensity was 2-3 times of the sensory threshold, for example, if the electrical stimulation intensity was 5 mA, 10-15 mA was used for stimulation), Record the specific value of current. FTEAS group pastes electrode piece, turns on the power, but there is no current output.
- Select L2/3 or L3/4 interval for spinal anesthesia, use 0.75% cloth ratio, and the dose standard is 0.025ml/Kg.
- Collect venous blood after entering the operating room and 30 minutes after anesthesia to measure the levels of neurotransmitters and hormones, record the baseline value of vital signs and changes during operation, observe the occurrence and treatment of adverse events during operation, and follow up the troponin T level and the incidence of delirium after operation.
- Remedial measures for clinical safety:
When severe hypotension occurs during operation, which leads to irreversible adverse effects, it needs to be intervened by multiple means.
Those who are diagnosed as delirium through CAM determination shall be treated with haloperidol or dexmedetomidine.
- Conditions
- Anesthesia
- Being tested
- Transcutaneous electric stimulation pretreatment, Transcutaneous acupoint electrical stimulation treatment, Transcutaneous acupoint pseudo electric stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electric stimulation pretreatmentDevice
Within 30 minutes before spinal anesthesia or 30 minutes after hypotension, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points, and the current intensity was only as high as the patient could comfortably tolerate (the electrical stimulation intensity was 2-3 times of the sensory threshold, for example, if the electrical stimulation intensity was 5 mA, 10-15 mA was used for stimulation), Record the specific value of current. FTEAS group pastes electrode piece, turns on the power, but there is no current output.
Transcutaneous acupoint electrical stimulation treatmentDevice
Transcutaneous acupoint electrical stimulation treatment
Transcutaneous acupoint pseudo electric stimulationDevice
Transcutaneous acupoint pseudo electric stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electric stimulation pretreatment group | Experimental | 30 minutes before the implementation of spinal anesthesia, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points. Receives: Device: Transcutaneous electric stimulation pretreatment |
| Transcutaneous acupoint electrical stimulation treatment group | Active comparator | Within 30 minutes after the occurrence of hypotension, TEAS (density wave 10/50Hz, one side of Neiguan point and Quchi point connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points. Receives: Device: Transcutaneous acupoint electrical stimulation treatment |
| Transcutaneous acupoint pseudo electric stimulation group | Sham comparator | Paste the electrode, turn on the power, but no current output. Receives: Device: Transcutaneous acupoint pseudo electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
30 mins after anesthesia, hypotension was defined as MAP<25% of the baseline value
Measured: 30 mins after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Feb 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ShuGuang Hospital
- Responsible party
- Principal investigator, Shaorui Gu, Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Wenli Wang, Doctor, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716399
- Sponsor's protocol ID
- 2021-984-59-01
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Stimulation of Acupoints on the Incidence of Hypotension After Spinal Anesthesia in Elderly Patients Undergoing Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT05716399
- Acronym / sponsor ID
- 2021-984-59-01
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- ShuGuang Hospital
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Feb 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.
This study is intended to include elderly patients who are selected to undergo lower limb and pelvic orthopedic surgery under spinal anesthesia. Through prospective, randomized and controlled clinical trials, the investigators will observe the effect of this treatment on the incidence of hypotension in elderly patients after spinal anesthesia through TEAS points Neiguan and Quchi before or during surgery, and further explore its related mechanisms.
Detailed description
Research content: This study aims to observe whether TEAS intervention on Neiguan (PC-6) and Quchi (LI-11) before and during operation can improve the incidence and degree of hypotension after spinal anesthesia, as well as the changes of neurotransmitters and related hormones in blood.
Research methods:
- 111 elderly patients (including hip or lower limb fractures, hip and knee joint replacement or debridement) who were selected for lower limb or pelvic surgery under spinal anesthesia were randomly divided into percutaneous point electrical stimulation pretreatment group (PTEAS group), percutaneous point electrical stimulation treatment group (TEAS group) and percutaneous point pseudo electrical stimulation group (FTEAS group).
- After entering the operating room, the vital signs were monitored routinely, and the volume was evaluated by measuring the variability of the inferior vena cava with ultrasound before anesthesia. Then, the radial artery was punctured and catheterized, and sodium lactate was infused (8ml/Kg).
- Within 30 minutes before spinal anesthesia or 30 minutes after hypotension, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points, and the current intensity was only as high as the patient could comfortably tolerate (the electrical stimulation intensity was 2-3 times of the sensory threshold, for example, if the electrical stimulation intensity was 5 mA, 10-15 mA was used for stimulation), Record the specific value of current. FTEAS group pastes electrode piece, turns on the power, but there is no current output.
- Select L2/3 or L3/4 interval for spinal anesthesia, use 0.75% cloth ratio, and the dose standard is 0.025ml/Kg.
- Collect venous blood after entering the operating room and 30 minutes after anesthesia to measure the levels of neurotransmitters and hormones, record the baseline value of vital signs and changes during operation, observe the occurrence and treatment of adverse events during operation, and follow up the troponin T level and the incidence of delirium after operation.
- Remedial measures for clinical safety:
When severe hypotension occurs during operation, which leads to irreversible adverse effects, it needs to be intervened by multiple means.
Those who are diagnosed as delirium through CAM determination shall be treated with haloperidol or dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electric stimulation pretreatment group | Experimental | Device: Transcutaneous electric stimulation pretreatment30 minutes before the implementation of spinal anesthesia, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points. |
| Transcutaneous acupoint electrical stimulation treatment group | Active comparator | Device: Transcutaneous acupoint electrical stimulation treatmentWithin 30 minutes after the occurrence of hypotension, TEAS (density wave 10/50Hz, one side of Neiguan point and Quchi point connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points. |
| Transcutaneous acupoint pseudo electric stimulation group | Sham comparator | Device: Transcutaneous acupoint pseudo electric stimulationPaste the electrode, turn on the power, but no current output. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 90>65, regardless of gender;
Key exclusion criteria (6 listed)
- Uncontrolled hypertension;
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 |
|---|---|---|
| Transcutaneous electric stimulation pretreatmentWithin 30 minutes before spinal anesthesia or 30 minutes after hypotension, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points, and the current intensity was only as high as the patient could comfortably tolerate (the electrical stimulation intensity was 2-3 times of the sensory threshold, for example, if the electrical stimulation intensity was 5 mA, 10-15 mA was used for stimulation), Record the specific value of current. FTEAS group pastes electrode piece, turns on the power, but there is no current output. | Device | Transcutaneous electric stimulation pretreatment group |
| Transcutaneous acupoint electrical stimulation treatmentTranscutaneous acupoint electrical stimulation treatment | Device | Transcutaneous acupoint electrical stimulation treatment group |
| Transcutaneous acupoint pseudo electric stimulationTranscutaneous acupoint pseudo electric stimulation | Device | Transcutaneous acupoint pseudo electric stimulation group |
Primary outcome
Incidence of hypotension
Time frame: 30 mins after anesthesia
30 mins after anesthesia, hypotension was defined as MAP<25% of the baseline value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
Wenli Wang, Doctor principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electric stimulation pretreatment, Transcutaneous acupoint electrical stimulation treatment and Transcutaneous acupoint pseudo electric stimulation in people with Anesthesia, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
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 2 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 8 Feb 2023. 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 Shaorui Gu, Doctor (051866111070, 870005908@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: 30 mins after anesthesia). 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 8 Feb 2023.