Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension
EARTH
1 other identifier
interventional
90
1 country
1
Brief Summary
The parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. Acupuncture was reported to treat hypotension both in human and animal studies. Possible mechanisms include modulating cardiovascular and sympathetic system. In this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (TEAS) on hypotension in parturients undergoing cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2023
CompletedDecember 19, 2023
December 1, 2023
6 months
February 2, 2023
December 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of hypotension by 30 minutes after spinal anesthesia
Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or \<90 mm Hg
from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Secondary Outcomes (8)
lowest systolic blood pressure during 30 minutes after spinal anesthesia
from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
dose of ephedrine
from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
nausea and vomiting score
from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of dizzy
from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of apnea
from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
- +3 more secondary outcomes
Study Arms (3)
control
SHAM COMPARATORlow frequency stimulation
EXPERIMENTALhigh frequency stimulation
EXPERIMENTALInterventions
electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given
electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given
electrodes are attached to area of acupoints
Eligibility Criteria
You may qualify if:
- age ≥18 years
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- singleton pregnancy
- full-term gestation (≥38 weeks)
You may not qualify if:
- Parturients suffering from preeclampsia
- Parturients with hypertension, diabetes, or cardiac dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhihong LUlead
Study Sites (1)
Xijing hospital, Fourth military medical university
Xi'an, Shaanxi, 710032, China
Related Publications (4)
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.
PMID: 17959591RESULTAdigun TA, Amanor-Boadu SD, Soyannwo OA. Comparison of intravenous ephedrine with phenylephrine for the maintenance of arterial blood pressure during elective caesarean section under spinal anaesthesia. Afr J Med Med Sci. 2010 Mar;39(1):13-20.
PMID: 20632667RESULTChooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.
PMID: 32619039RESULTLiu X, Gao Z, Jiang Y, Tuo X, He S, Xu F, Lu Z. Comparison of Low-Frequency or High-Frequency Electrical Acupoint Stimulation on Hypotension After Spinal Anesthesia in Parturients: A Prospective Randomized Controlled Clinical Trial. J Integr Complement Med. 2024 Aug;30(8):770-775. doi: 10.1089/jicm.2023.0610. Epub 2024 Mar 28.
PMID: 38546428DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 2, 2023
First Posted
February 13, 2023
Study Start
February 20, 2023
Primary Completion
August 29, 2023
Study Completion
August 29, 2023
Last Updated
December 19, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share