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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
wangqiang, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01930227
First received: August 24, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Hypotension
Other: TEAS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Incidence of hypotension [ Time Frame: During 30min after spinal anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average systemic blood pressure(SBP) and diastolic blood pressure(DBP) [ Time Frame: During 30min after spinal anesthesia ] [ Designated as safety issue: No ]
  • Lowest SBP and DBP [ Time Frame: During 30min after spinal anesthesia ] [ Designated as safety issue: No ]
  • Dosage of ephedrine [ Time Frame: During 30min after spinal anesthesia ] [ Designated as safety issue: No ]
  • postoperative nausea and vomiting(PONV) score [ Time Frame: During 30min after spinal anesthesia ] [ Designated as safety issue: No ]
  • Incidence of dizzy and dyspnea [ Time Frame: During 30min after spinal anesthesia ] [ Designated as safety issue: No ]
  • Change of concentration of serum adrenaline and noradrenaline [ Time Frame: Immediately after TEAS ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TEAS Treatment
Patients were given 30min of TEAS after spinal anesthesia
Other: TEAS
Electric stimulation was given through electrode attached to specific acupoints
Other Name: Transcutaneous electriv acupoint stimulation
Experimental: TEAS Pretreatment
Patients were given 30min of TEAS before spinal anesthesia
Other: TEAS
Electric stimulation was given through electrode attached to specific acupoints
Other Name: Transcutaneous electriv acupoint stimulation

Detailed Description:

Patients were randomly assigned to two groups, receiving TEAS before and 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930227

Contacts
Contact: Qiang Wang 86-29-84775343 wangqiang@fmmu.edu.cn

Locations
China, Shaanxi
Women and Children's Hospital of Shaanxi Province Active, not recruiting
Xi'an, Shaanxi, China, 710000
Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Hailong Dong    86-29-84775337    hldong6@hotmail.com   
Principal Investigator: Zhihong LU         
Sub-Investigator: Zijun GAO         
Sponsors and Collaborators
wangqiang
Investigators
Principal Investigator: Zhihong LU, MD Xijing hospital, Fourth military medical university
  More Information

Publications:
Responsible Party: wangqiang, Professor, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01930227     History of Changes
Other Study ID Numbers: XJH-A-2013-08-1
Study First Received: August 24, 2013
Last Updated: May 5, 2014
Health Authority: China: Ministry of Health

Keywords provided by Xijing Hospital:
hypotension
spinal anesthesia
cesarean

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014