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Completed

NCT Number: NCT05163990

Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia

The purpose of this study is to assess the prevention and treatment effect of transcutaneous acupoint electrical stimulation on hypotension after intraspinal anesthesia.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Transcutaneous acupoint electrical stimulation

Other

The corresponding transcutaneous acupoint electrical stimulation is given to different groups before spinal anesthesia, which last from 10 minutes before anesthesia to 30 minutes after subarachnoid administration.

Primary outcomes

  1. incidence of hypotension

    Time frame: 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 outcomes

  1. specific changes of hemodynamic indexes

    Time frame: within 30 minutes after subarachnoid administration

    compared with Control group, the changes of hemodynamic indexes in TEAS group were more stable.

  2. usage of ephedrine

    Time frame: 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.

  3. incidence of nausea and vomiting

    Time frame: 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.

  4. incidence of dizziness, chest tightness and dyspnea

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Based on Non-invasive Cardiac Output Monitoring System to Explore the Preventive and Therapeutic Effect of Transcutaneous Acupoint Electrical Stimulation on Hypotension After Intraspinal Anesthesia in Cesarean Section

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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