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

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TEAS
Non-acupoint stimulation
Sponsored by
wangqiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring hypotension, spinal anesthesia, cesarean

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women and Children's Hospital of Shaanxi Province
  • Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

TEAS Treatment

Non-acupoint stimulation

Control

Arm Description

Patients were given 30min of TEAS at PC6 after spinal anesthesia

Patients were given 30min of electrical stimulation at shoulder after spinal anesthesia

No stimulation was given

Outcomes

Primary Outcome Measures

Incidence of hypotension

Secondary Outcome Measures

Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)
Lowest SBP and DBP
Dosage of ephedrine
postoperative nausea and vomiting(PONV) score
Incidence of dizzy and dyspnea
Change of concentration of serum adrenaline and noradrenaline

Full Information

First Posted
August 24, 2013
Last Updated
December 7, 2014
Sponsor
wangqiang
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1. Study Identification

Unique Protocol Identification Number
NCT01930227
Brief Title
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
Acronym
THSAP
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
wangqiang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
hypotension, spinal anesthesia, cesarean

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEAS Treatment
Arm Type
Experimental
Arm Description
Patients were given 30min of TEAS at PC6 after spinal anesthesia
Arm Title
Non-acupoint stimulation
Arm Type
Sham Comparator
Arm Description
Patients were given 30min of electrical stimulation at shoulder after spinal anesthesia
Arm Title
Control
Arm Type
No Intervention
Arm Description
No stimulation was given
Intervention Type
Other
Intervention Name(s)
TEAS
Other Intervention Name(s)
Transcutaneous electrical acupoint stimulation
Intervention Description
Electric stimulation was given through electrode attached to specific acupoints
Intervention Type
Other
Intervention Name(s)
Non-acupoint stimulation
Intervention Description
Electric stimulation was given through electrode attached to the shoulder
Primary Outcome Measure Information:
Title
Incidence of hypotension
Time Frame
During 30min after spinal anesthesia
Secondary Outcome Measure Information:
Title
Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)
Time Frame
During 30min after spinal anesthesia
Title
Lowest SBP and DBP
Time Frame
During 30min after spinal anesthesia
Title
Dosage of ephedrine
Time Frame
During 30min after spinal anesthesia
Title
postoperative nausea and vomiting(PONV) score
Time Frame
During 30min after spinal anesthesia
Title
Incidence of dizzy and dyspnea
Time Frame
During 30min after spinal anesthesia
Title
Change of concentration of serum adrenaline and noradrenaline
Time Frame
Immediately after TEAS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong LU, MD
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women and Children's Hospital of Shaanxi Province
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22309902
Citation
Sahmeddini MA, Eghbal MH, Khosravi MB, Ghaffaripour S, Janatmakan F, Shokrizade S. Electro-acupuncture stimulation at acupoints reduced the severity of hypotension during anesthesia in patients undergoing liver transplantation. J Acupunct Meridian Stud. 2012 Feb;5(1):11-4. doi: 10.1016/j.jams.2011.11.001. Epub 2011 Dec 7.
Results Reference
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PubMed Identifier
17959591
Citation
Arai YC, Kato N, Matsura M, Ito H, Kandatsu N, Kurokawa S, Mizutani M, Shibata Y, Komatsu T. Transcutaneous electrical nerve stimulation at the PC-5 and PC-6 acupoints reduced the severity of hypotension after spinal anaesthesia in patients undergoing Caesarean section. Br J Anaesth. 2008 Jan;100(1):78-81. doi: 10.1093/bja/aem306. Epub 2007 Oct 24.
Results Reference
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PubMed Identifier
12893654
Citation
Syuu Y, Matsubara H, Hosogi S, Suga H. Pressor effect of electroacupuncture on hemorrhagic hypotension. Am J Physiol Regul Integr Comp Physiol. 2003 Dec;285(6):R1446-52. doi: 10.1152/ajpregu.00243.2003. Epub 2003 Jul 31.
Results Reference
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Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients

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