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

NCT ID: NCT05163990

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-05-31

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).

Conditions

Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

transcutaneous acupoint electrical stimulation

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transcutaneous acupoint electrical stimulation

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Wang, doctor

Role: STUDY_CHAIR

First Affiliated Hospital of Xian Jiaotong University

Ying Xiao, doctor

Role: STUDY_DIRECTOR

First Affiliated Hospital of Xian Jiaotong University

Juan Bai, doctor

Role: STUDY_DIRECTOR

First Affiliated Hospital of Xian Jiaotong University

Meng Yue Xu, postgraduate

Role: PRINCIPAL_INVESTIGATOR

Shaanxi University of Chinese Medicine

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Countries

China

References

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)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

XJTU1AF2021LSK-332

Identifier Type: -

Identifier Source: org_study_id