Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia
- Conditions
- Hypotension
- Interventions
- Other: transcutaneous acupoint electrical stimulation
- Registration Number
- NCT05163990
- Brief Summary
The purpose of this study is to assess the prevention and treatment effect of transcutaneous acupoint electrical stimulation on hypotension after intraspinal anesthesia.
- Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo the doctors' and researchers' examination to determine eligibility for study entry. At beginning of the study, patients who meet the eligibility requirements will be randomized in a open manner（participant and electroacupuncture executor）in a 1:1 ratio to TEAS group (10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration) or Control group (Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 64
- 18 years ≤ age < 55 years
- ASA classification I ~ II
- full term (37 weeks ≤ gestational weeks < 42 weeks)
- fchedule for elective single cesarean section under spinal anesthesia
- no other clinical trial 3 months before the enrollment
- volunteer to participate and sign the informed consent form
- severe preeclampsia or hypertension
- diabetes
- cardiac insufficiency
- mental abnormality or cognitive impairment or inability to communicate
- acupuncture points skin breakage, infection, allergy
- the researchers believe that there are any conditions that are not suitable for inclusion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEAS group transcutaneous acupoint electrical stimulation 10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration.
- Primary Outcome Measures
Name Time Method incidence of hypotension within 30 minutes after subarachnoid administration the incidence of hypotension within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
- Secondary Outcome Measures
Name Time Method incidence of nausea and vomiting within 30 minutes after subarachnoid administration the incidence of nausea and vomiting within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
incidence of dizziness, chest tightness and dyspnea within 30 minutes after subarachnoid administration the incidence of dizziness, chest tightness and dyspnea within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
specific changes of hemodynamic indexes within 30 minutes after subarachnoid administration compared with Control group, the changes of hemodynamic indexes in TEAS group were more stable.
usage of ephedrine within 30 minutes after subarachnoid administration the usage of ephedrine within 30 minutes after subarachnoid administration in TEAS group was significantly less than that in Control group.
Trial Locations
- Locations (1)
First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xi'an, Shaanxi, China