Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension

NCT ID: NCT05724095

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-08-29

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension During Surgery

Keywords

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transcutaneous electrical acupoint stimulation spinal anesthesia hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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control

Group Type SHAM_COMPARATOR

electrodes attached

Intervention Type OTHER

electrodes are attached to area of acupoints

low frequency stimulation

Group Type EXPERIMENTAL

low frequency acupoint stimulation

Intervention Type OTHER

electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given

electrodes attached

Intervention Type OTHER

electrodes are attached to area of acupoints

high frequency stimulation

Group Type EXPERIMENTAL

high frequency acupoint stimulation

Intervention Type OTHER

electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given

electrodes attached

Intervention Type OTHER

electrodes are attached to area of acupoints

Interventions

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high frequency acupoint stimulation

electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given

Intervention Type OTHER

low frequency acupoint stimulation

electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given

Intervention Type OTHER

electrodes attached

electrodes are attached to area of acupoints

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age ≥18 years
* American Society of Anesthesiologists physical status Ⅰ-Ⅱ
* singleton pregnancy
* full-term gestation (≥38 weeks)

Exclusion Criteria

* Parturients suffering from preeclampsia
* Parturients with hypertension, diabetes, or cardiac dysfunction
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhihong LU

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Xijing hospital, Fourth military medical university

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 17959591 (View on PubMed)

Adigun 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.

Reference Type RESULT
PMID: 20632667 (View on PubMed)

Chooi 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.

Reference Type RESULT
PMID: 32619039 (View on PubMed)

Liu 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.

Reference Type DERIVED
PMID: 38546428 (View on PubMed)

Other Identifiers

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XJH-20230203

Identifier Type: -

Identifier Source: org_study_id