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
About this trial
This is an interventional prevention trial for Hypotension
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.
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
NCT ID
NCT05163990
First Posted
November 10, 2021
Last Updated
July 17, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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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