Hypotension During SurgeryEARTHNCT05724095
Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension
A study testing high frequency acupoint stimulation, low frequency acupoint stimulation and electrodes attached in people with Hypotension During Surgery, run by Zhihong LU at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- high frequency acupoint stimulation, low frequency acupoint stimulation and electrodes attached
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 29 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- singleton pregnancy
- full-term gestation (≥38 weeks)
Who cannot join
- Parturients suffering from preeclampsia
- Parturients with hypertension, diabetes, or cardiac dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing hospital, Fourth military medical university
Xi'an, Shaanxi, 710032
About this study
Official title: 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.
- Conditions
- Hypotension During Surgery
- Being tested
- high frequency acupoint stimulation, low frequency acupoint stimulation, electrodes attached
- Keywords
- transcutaneous electrical acupoint stimulation, spinal anesthesia, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency acupoint stimulationOther
electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given
low frequency acupoint stimulationOther
electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given
electrodes attachedOther
electrodes are attached to area of acupoints
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | Not described Receives: Other: electrodes attached |
| low frequency stimulation | Experimental | Not described Receives: Other: low frequency acupoint stimulation; Other: electrodes attached |
| high frequency stimulation | Experimental | Not described Receives: Other: high frequency acupoint stimulation; Other: electrodes attached |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Secondary outcomes (8)
lowest systolic blood pressure during 30 minutes after spinal anesthesia
Measured: 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
Measured: 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.
Measured: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of dizzy
Measured: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of apnea
Measured: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of chest congestion
Measured: 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
Measured: 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.
Measured: 1minute after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Feb 2023
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724095
- Sponsor's protocol ID
- XJH-20230203
- Acronym
- EARTH
- Status last verified
- Dec 2023
- First submitted
- 2 Feb 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17959591Adigun 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.
PubMed 20632667Chooi 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.
PubMed 32619039Liu X, Gao Z, Jiang Y, Tuo X, He S, Xu F, Lu Z. Comparison of Low-Frequency or High-Frequency Electrical Acupoint Stimulation on Hypotension After Spinal Anesthesia in Parturients: A Prospective Randomized Controlled Clinical Trial. J Integr Complement Med. 2024 Aug;30(8):770-775. doi: 10.1089/jicm.2023.0610. Epub 2024 Mar 28.
PubMed 38546428
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05724095
- Acronym / sponsor ID
- EARTH / XJH-20230203
- Conditions
- Hypotension During Surgery
- Keywords
- transcutaneous electrical acupoint stimulation, spinal anesthesia, hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Other: electrodes attached |
| low frequency stimulation | Experimental | Other: low frequency acupoint stimulation, Other: electrodes attached |
| high frequency stimulation | Experimental | Other: high frequency acupoint stimulation, Other: electrodes attached |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 years
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- singleton pregnancy
- full-term gestation (≥38 weeks)
Key exclusion criteria (2 listed)
- Parturients suffering from preeclampsia
- Parturients with hypertension, diabetes, or cardiac dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high frequency acupoint stimulationelectrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given | Other | high frequency stimulation |
| low frequency acupoint stimulationelectrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given | Other | low frequency stimulation |
| electrodes attachedelectrodes are attached to area of acupoints | Other | control, high frequency stimulation, low frequency stimulation |
Primary outcome
incidence of hypotension by 30 minutes after spinal anesthesia
Time frame: 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
8 secondary outcomes
lowest systolic blood pressure during 30 minutes after spinal anesthesia
Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
dose of ephedrine
Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
nausea and vomiting score
Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of dizzy
Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of apnea
Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
incidence of chest congestion
Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
dose of atropine
Time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Apgar score at 1 minute
Time frame: 1minute after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Results publication: PubMed 17959591Arai 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.
- Results publication: PubMed 20632667Adigun 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.
- Results publication: PubMed 32619039Chooi 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.
- Derived from this study: PubMed 38546428Liu X, Gao Z, Jiang Y, Tuo X, He S, Xu F, Lu Z. Comparison of Low-Frequency or High-Frequency Electrical Acupoint Stimulation on Hypotension After Spinal Anesthesia in Parturients: A Prospective Randomized Controlled Clinical Trial. J Integr Complement Med. 2024 Aug;30(8):770-775. doi: 10.1089/jicm.2023.0610. Epub 2024 Mar 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high frequency acupoint stimulation, low frequency acupoint stimulation and electrodes attached in people with Hypotension During Surgery, run by Zhihong LU at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypotension by 30 minutes after spinal anesthesia (time frame: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724095, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.