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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01930227
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
wangqiang, Xijing Hospital

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

Condition or disease Intervention/treatment
Hypotension Other: TEAS Other: Non-acupoint stimulation

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2013
Primary Completion Date : August 2014
Study Completion Date : August 2014

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: TEAS Treatment
Patients were given 30min of TEAS at PC6 after spinal anesthesia
Other: TEAS
Electric stimulation was given through electrode attached to specific acupoints
Other Name: Transcutaneous electrical acupoint stimulation
Sham Comparator: Non-acupoint stimulation
Patients were given 30min of electrical stimulation at shoulder after spinal anesthesia
Other: Non-acupoint stimulation
Electric stimulation was given through electrode attached to the shoulder
No Intervention: Control
No stimulation was given

Primary Outcome Measures :
  1. Incidence of hypotension [ Time Frame: During 30min after spinal anesthesia ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01930227

China, Shaanxi
Women and Children's Hospital of Shaanxi Province
Xi'an, Shaanxi, China, 710000
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Principal Investigator: Zhihong LU, MD Fourth Military Medical University