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Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous acupoint electrical stimulation
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years ≤ age < 55 years
  • ASA classification I ~ II
  • full term (37 weeks ≤ gestational weeks < 42 weeks)
  • fchedule for elective single cesarean section under spinal anesthesia
  • no other clinical trial 3 months before the enrollment
  • volunteer to participate and sign the informed consent form

Exclusion Criteria:

  • severe preeclampsia or hypertension
  • diabetes
  • cardiac insufficiency
  • mental abnormality or cognitive impairment or inability to communicate
  • acupuncture points skin breakage, infection, allergy
  • the researchers believe that there are any conditions that are not suitable for inclusion.

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TEAS group

Control group

Arm Description

10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration.

Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group.

Outcomes

Primary Outcome Measures

incidence of hypotension
the incidence of hypotension within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.

Secondary Outcome Measures

specific changes of hemodynamic indexes
compared with Control group, the changes of hemodynamic indexes in TEAS group were more stable.
usage of ephedrine
the usage of ephedrine within 30 minutes after subarachnoid administration in TEAS group was significantly less than that in Control group.
incidence of nausea and vomiting
the incidence of nausea and vomiting within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
incidence of dizziness, chest tightness and dyspnea
the incidence of dizziness, chest tightness and dyspnea within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.

Full Information

First Posted
November 10, 2021
Last Updated
July 17, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05163990
Brief Title
Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia
Official Title
Based on Non-invasive Cardiac Output Monitoring System to Explore the Preventive and Therapeutic Effect of Transcutaneous Acupoint Electrical Stimulation on Hypotension After Intraspinal Anesthesia in Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the prevention and treatment effect of transcutaneous acupoint electrical stimulation on hypotension after intraspinal anesthesia.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo the doctors' and researchers' examination to determine eligibility for study entry. At beginning of the study, patients who meet the eligibility requirements will be randomized in a open manner(participant and electroacupuncture executor)in a 1:1 ratio to TEAS group (10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration) or Control group (Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
TEAS group: 10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration. Control group: Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEAS group
Arm Type
Experimental
Arm Description
10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group.
Intervention Type
Other
Intervention Name(s)
transcutaneous acupoint electrical stimulation
Intervention Description
The corresponding transcutaneous acupoint electrical stimulation is given to different groups before spinal anesthesia, which last from 10 minutes before anesthesia to 30 minutes after subarachnoid administration.
Primary Outcome Measure Information:
Title
incidence of hypotension
Description
the incidence of hypotension within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
Time Frame
within 30 minutes after subarachnoid administration
Secondary Outcome Measure Information:
Title
specific changes of hemodynamic indexes
Description
compared with Control group, the changes of hemodynamic indexes in TEAS group were more stable.
Time Frame
within 30 minutes after subarachnoid administration
Title
usage of ephedrine
Description
the usage of ephedrine within 30 minutes after subarachnoid administration in TEAS group was significantly less than that in Control group.
Time Frame
within 30 minutes after subarachnoid administration
Title
incidence of nausea and vomiting
Description
the incidence of nausea and vomiting within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
Time Frame
within 30 minutes after subarachnoid administration
Title
incidence of dizziness, chest tightness and dyspnea
Description
the incidence of dizziness, chest tightness and dyspnea within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
Time Frame
within 30 minutes after subarachnoid administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years ≤ age < 55 years ASA classification I ~ II full term (37 weeks ≤ gestational weeks < 42 weeks) fchedule for elective single cesarean section under spinal anesthesia no other clinical trial 3 months before the enrollment volunteer to participate and sign the informed consent form Exclusion Criteria: severe preeclampsia or hypertension diabetes cardiac insufficiency mental abnormality or cognitive impairment or inability to communicate acupuncture points skin breakage, infection, allergy the researchers believe that there are any conditions that are not suitable for inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wang, doctor
Organizational Affiliation
First Affiliated Hospital of Xian Jiaotong University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ying Xiao, doctor
Organizational Affiliation
First Affiliated Hospital of Xian Jiaotong University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juan Bai, doctor
Organizational Affiliation
First Affiliated Hospital of Xian Jiaotong University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Meng Yue Xu, postgraduate
Organizational Affiliation
Shaanxi University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
result

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Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia

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