Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension (EARTH)

Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypotension During Surgery
• Intervention / Treatment: Other: electrodes attached; Other: low frequency acupoint stimulation; Other: high frequency acupoint stimulation

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control	Other: electrodes attached; electrodes are attached to area of acupoints
Experimental: low frequency stimulation	Other: electrodes attached; electrodes are attached to area of acupoints; Other: low frequency acupoint stimulation; electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given
Experimental: high frequency stimulation	Other: electrodes attached; electrodes are attached to area of acupoints; Other: high frequency acupoint stimulation; electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	hypotension is treated with ephedrine in increments of 10 mg every 2 minutes	from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
nausea and vomiting score	The presence of nausea and vomiting is measured on a 3-point scale of 1, 2, and 3, indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively.	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
incidence of chest congestion		from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
dose of atropine	Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine	from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Apgar score at 1 minute	Apgar score of the neonates at 1minute after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.	1minute after birth

Collaborators and Investigators

• Sponsor: Zhihong LU

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: spinal anesthesia; transcutaneous electrical acupoint stimulation; hypotension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: XJH-20230203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No