Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension

Not Applicable

Completed

• Conditions: Hypotension During Surgery
• Interventions: Other: low frequency acupoint stimulation; Other: high frequency acupoint stimulation; Other: electrodes attached

• Registration Number: NCT05724095
• Lead Sponsor: Zhihong LU

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Study Start: 2023-02-20
• Primary Completion: 2023-08-29
• Study Completion: 2023-08-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low frequency stimulation	low frequency acupoint stimulation	-
low frequency stimulation	electrodes attached	-
high frequency stimulation	high frequency acupoint stimulation	-
high frequency stimulation	electrodes attached	-
control	electrodes attached	-

Primary Outcome Measures

Name	Time	Method
incidence of hypotension by 30 minutes after spinal anesthesia	from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes	Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or \<90 mm Hg

Secondary Outcome Measures

Name	Time	Method
dose of ephedrine	from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes	hypotension is treated with ephedrine in increments of 10 mg every 2 minutes
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
incidence of apnea	from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
nausea and vomiting score	from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes	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.
incidence of dizzy	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	from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes	Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine
Apgar score at 1 minute	1minute after birth	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.

Trial Locations

Locations (1)

Xijing hospital, Fourth military medical university; 🇨🇳 Xi'an, Shaanxi, China