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Completed

NCT Number: NCT05724095

Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension

The parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. Acupuncture was reported to treat hypotension both in human and animal studies. Possible mechanisms include modulating cardiovascular and sympathetic system. In this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (TEAS) on hypotension in parturients undergoing cesarean section.

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Key information

Conditions

Hypotension During Surgery Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xijing hospital, Fourth military medical university

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥18 years
  • American Society of Anesthesiologists physical status Ⅰ-Ⅱ
  • singleton pregnancy
  • full-term gestation (≥38 weeks)

Exclusion criteria

  • Parturients suffering from preeclampsia
  • Parturients with hypertension, diabetes, or cardiac dysfunction

Treatment and study plan

high frequency acupoint stimulation

Other

electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given

low frequency acupoint stimulation

Other

electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given

electrodes attached

Other

electrodes are attached to area of acupoints

Primary outcomes

  1. incidence of hypotension by 30 minutes after spinal anesthesia

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

    Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or <90 mm Hg

Secondary outcomes

  1. lowest systolic blood pressure during 30 minutes after spinal anesthesia

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

  2. dose of ephedrine

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

    hypotension is treated with ephedrine in increments of 10 mg every 2 minutes

  3. nausea and vomiting score

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

    The presence of nausea and vomiting is measured on a 3-point scale of 1, 2, and 3, indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively.

  4. incidence of dizzy

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

  5. incidence of apnea

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

  6. incidence of chest congestion

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

  7. dose of atropine

    Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes

    Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine

  8. Apgar score at 1 minute

    Time frame: 1minute after birth

    Apgar score of the neonates at 1minute after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.

Sponsors and collaborators

Lead sponsor

Zhihong LU

Other

Registry information

Official study title

Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial

Acronym: EARTH

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Dec 19, 2023

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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