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Completed

NCT Number: NCT01930227

Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients

The purpose of this study is to compare the effect of TEAS on hypotension after spinal anesthesia in patients undergoing cesarean section

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Children's Hospital of Shaanxi Province, Xi'an, Shaanxi, China

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About this study

Patients were randomly assigned to 3 groups, receiving TEAS , non-acupoint stimulation or no-stimulation after spinal anesthesia respectively. 1.4 ml of bupivacaine mixed with 0.2ml of 50% glucose was given for spinal anesthesia under lateral position. Then the patient was switched to supine position and the OR table was tilted to the left for 15 degree. The sensory loss level was assessed. The blood pressure and heart rate every 2min were recorded for 30min after spinal anesthesia. The adverse events and use of ephedrine adverse events were recorded as well.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age>18yrs
  • American Society of Anesthesiologists(ASA) status 1-2
  • Scheduled for elective cesarean under spinal anesthesia
  • Gestational age>38weeks, singleton pregnancy
  • Informed consented

Exclusion criteria

  • Patients with pre-eclampsia or diabetes
  • Patients with hypertension or cardiac dysfunction
  • Disturbance of communication
  • Placental abruption

Treatment and study plan

TEAS

Other

Electric stimulation was given through electrode attached to specific acupoints

Other names: Transcutaneous electrical acupoint stimulation

non-acupoint stimulation

Other

Electric stimulation was given through electrode attached to the shoulder

Primary outcomes

  1. Incidence of hypotension

    Time frame: During 30min after spinal anesthesia

Secondary outcomes

  1. Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)

    Time frame: During 30min after spinal anesthesia

  2. Lowest SBP and DBP

    Time frame: During 30min after spinal anesthesia

  3. Dosage of ephedrine

    Time frame: During 30min after spinal anesthesia

  4. postoperative nausea and vomiting(PONV) score

    Time frame: During 30min after spinal anesthesia

  5. Incidence of dizzy and dyspnea

    Time frame: During 30min after spinal anesthesia

  6. Change of concentration of serum adrenaline and noradrenaline

    Time frame: Immediately after TEAS

Sponsors and collaborators

Lead sponsor

wangqiang

Other

Registry information

Official study title

Effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section: a Prospective, Randomized Controlled Trial

Acronym: THSAP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2013
Registry last updated
Dec 9, 2014

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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