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

December 7, 2014 updated by: wangqiang

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University
      • Xi'an, Shaanxi, China, 710000
        • Women and Children's Hospital of Shaanxi Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of hypotension
Time Frame: During 30min after spinal anesthesia
During 30min after spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)
Time Frame: During 30min after spinal anesthesia
During 30min after spinal anesthesia
Lowest SBP and DBP
Time Frame: During 30min after spinal anesthesia
During 30min after spinal anesthesia
Dosage of ephedrine
Time Frame: During 30min after spinal anesthesia
During 30min after spinal anesthesia
postoperative nausea and vomiting(PONV) score
Time Frame: During 30min after spinal anesthesia
During 30min after spinal anesthesia
Incidence of dizzy and dyspnea
Time Frame: During 30min after spinal anesthesia
During 30min after spinal anesthesia
Change of concentration of serum adrenaline and noradrenaline
Time Frame: Immediately after TEAS
Immediately after TEAS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

wangqiang

Investigators

  • Principal Investigator: zhihong Lu, MD, Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 24, 2013

First Submitted That Met QC Criteria

August 24, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 7, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-2013-08-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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