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

NCT05163990 | Completed

• 1 other identifier: XJTU1AF2021LSK-332
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• incidence of hypotension

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

  within 30 minutes after subarachnoid administration

Secondary Outcomes (4)

• specific changes of hemodynamic indexes

  within 30 minutes after subarachnoid administration

• usage of ephedrine

  within 30 minutes after subarachnoid administration

• incidence of nausea and vomiting

  within 30 minutes after subarachnoid administration

• incidence of dizziness, chest tightness and dyspnea

  within 30 minutes after subarachnoid administration

Study Arms (2)

TEAS group

EXPERIMENTAL

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.

Other: transcutaneous acupoint electrical stimulation

Control group

NO INTERVENTION

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.

Interventions

transcutaneous acupoint electrical stimulation 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.

TEAS group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• severe preeclampsia or hypertension
• diabetes
• cardiac insufficiency
• mental abnormality or cognitive impairment or inability to communicate
• acupuncture points skin breakage, infection, allergy

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• 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: 17959591 RESULT

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qiang Wang, doctor

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

• Ying Xiao, doctor

  First Affiliated Hospital of Xian Jiaotong University

  STUDY DIRECTOR

• Juan Bai, doctor

  First Affiliated Hospital of Xian Jiaotong University

  STUDY DIRECTOR

• Meng Yue Xu, postgraduate

  Shaanxi University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 20, 2021
• Study Start: November 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 20, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)