Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension

Hypotension During Surgery Clinical Trial

— EARTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05724095
• Other study ID #: XJH-20230203
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 29, 2023

Study information

• Verified date: December 2023
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years

• American Society of Anesthesiologists physical status ?-?

• singleton pregnancy

• full-term gestation (=38 weeks)

Exclusion Criteria:

• Parturients suffering from preeclampsia

• Parturients with hypertension, diabetes, or cardiac dysfunction

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Surgery

Intervention

Other:
• high frequency acupoint stimulation
electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given
• low frequency acupoint stimulation
electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given
• electrodes attached
electrodes are attached to area of acupoints

Locations

Country	Name	City	State
China	Xijing hospital, Fourth military medical university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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 Cae — View Citation

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.p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	incidence of dizzy		from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Secondary	incidence of apnea		from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Secondary	incidence of chest congestion		from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Secondary	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
Secondary	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