Clinical trial NCT05724095: Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension
Official title: Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension During Surgery
Keywords: transcutaneous electrical acupoint stimulation
spinal anesthesia
hypotension
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of hypotension by 30 minutes after spinal anesthesia
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Secondary outcomes:
measure: lowest systolic blood pressure during 30 minutes after spinal anesthesia
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
measure: dose of ephedrine
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
measure: nausea and vomiting score
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
measure: incidence of dizzy
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
measure: incidence of apnea
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
measure: incidence of chest congestion
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
measure: dose of atropine
timeFrame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
measure: Apgar score at 1 minute
timeFrame: 1minute after birth
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital, Fourth military medical university
state: Shaanxi
Study officials:
References:
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 Caesarean section. Br J Anaesth. 2008 Jan;100(1):78-81. doi: 10.1093/bja/aem306. Epub 2007 Oct 24.
citation: 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.
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.pub4.