HypotensionTHSAPNCT01930227
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
A study testing TEAS and Non-acupoint stimulation in people with Hypotension, run by wangqiang at 2 sites in China.
Trial summary
The purpose of this study is to compare the effect of TEAS on hypotension after spinal anesthesia in patients undergoing cesarean section Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- TEAS and Non-acupoint stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2013to Aug 2014
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18yrs
- American Society of Anesthesiologists(ASA) status 1-2
- Scheduled for elective cesarean under spinal anesthesia
- Gestational age>38weeks, singleton pregnancy
- Informed consented
Who cannot join
- Patients with pre-eclampsia or diabetes
- Patients with hypertension or cardiac dysfunction
- Disturbance of communication
- Placental abruption
Trial locations and contacts
2 sites in 1 country.
China2 sites
Women and Children's Hospital of Shaanxi Province
Xi'an, Shaanxi, 710000
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section: a Prospective, Randomized Controlled Trial
The purpose of this study is to compare the effect of TEAS on hypotension after spinal anesthesia in patients undergoing cesarean section
Read the detailed description
Patients were randomly assigned to 3 groups, receiving TEAS , non-acupoint stimulation or no-stimulation after spinal anesthesia respectively. 1.4 ml of bupivacaine mixed with 0.2ml of 50% glucose was given for spinal anesthesia under lateral position. Then the patient was switched to supine position and the OR table was tilted to the left for 15 degree. The sensory loss level was assessed. The blood pressure and heart rate every 2min were recorded for 30min after spinal anesthesia. The adverse events and use of ephedrine adverse events were recorded as well.
- Conditions
- Hypotension
- Being tested
- TEAS, Non-acupoint stimulation
- Keywords
- hypotension, spinal anesthesia, cesarean
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASOther
Also called Transcutaneous electrical acupoint stimulation
Electric stimulation was given through electrode attached to specific acupoints
Non-acupoint stimulationOther
Electric stimulation was given through electrode attached to the shoulder
| Study group | Role | What they receive |
|---|---|---|
| TEAS Treatment | Experimental | Patients were given 30min of TEAS at PC6 after spinal anesthesia Receives: Other: TEAS |
| Non-acupoint stimulation | Sham comparator | Patients were given 30min of electrical stimulation at shoulder after spinal anesthesia Receives: Other: Non-acupoint stimulation |
| Control | No intervention | No stimulation was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
Measured: During 30min after spinal anesthesia
Secondary outcomes (6)
Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)
Measured: During 30min after spinal anesthesia
Lowest SBP and DBP
Measured: During 30min after spinal anesthesia
Dosage of ephedrine
Measured: During 30min after spinal anesthesia
postoperative nausea and vomiting(PONV) score
Measured: During 30min after spinal anesthesia
Incidence of dizzy and dyspnea
Measured: During 30min after spinal anesthesia
Change of concentration of serum adrenaline and noradrenaline
Measured: Immediately after TEAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- wangqiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wangqiang, Xijing Hospital
- Investigators
- Zhihong LU, MD, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930227
- Sponsor's protocol ID
- XJH-A-2013-08-1
- Acronym
- THSAP
- Status last verified
- Dec 2014
- First submitted
- 24 Aug 2013
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sahmeddini MA, Eghbal MH, Khosravi MB, Ghaffaripour S, Janatmakan F, Shokrizade S. Electro-acupuncture stimulation at acupoints reduced the severity of hypotension during anesthesia in patients undergoing liver transplantation. J Acupunct Meridian Stud. 2012 Feb;5(1):11-4. doi: 10.1016/j.jams.2011.11.001. Epub 2011 Dec 7.
PubMed 22309902Arai 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 17959591Syuu Y, Matsubara H, Hosogi S, Suga H. Pressor effect of electroacupuncture on hemorrhagic hypotension. Am J Physiol Regul Integr Comp Physiol. 2003 Dec;285(6):R1446-52. doi: 10.1152/ajpregu.00243.2003. Epub 2003 Jul 31.
PubMed 12893654
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01930227
- Acronym / sponsor ID
- THSAP / XJH-A-2013-08-1
- Conditions
- Hypotension
- Keywords
- hypotension, spinal anesthesia, cesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- wangqiangUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Aug 2013 (estimated)
- 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 purpose of this study is to compare the effect of TEAS on hypotension after spinal anesthesia in patients undergoing cesarean section
Detailed description
Patients were randomly assigned to 3 groups, receiving TEAS , non-acupoint stimulation or no-stimulation after spinal anesthesia respectively. 1.4 ml of bupivacaine mixed with 0.2ml of 50% glucose was given for spinal anesthesia under lateral position. Then the patient was switched to supine position and the OR table was tilted to the left for 15 degree. The sensory loss level was assessed. The blood pressure and heart rate every 2min were recorded for 30min after spinal anesthesia. The adverse events and use of ephedrine adverse events were recorded as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEAS Treatment | Experimental | Other: TEASPatients were given 30min of TEAS at PC6 after spinal anesthesia |
| Non-acupoint stimulation | Sham comparator | Other: Non-acupoint stimulationPatients were given 30min of electrical stimulation at shoulder after spinal anesthesia |
| Control | No intervention | –No stimulation was given |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>18yrs
- American Society of Anesthesiologists(ASA) status 1-2
- Scheduled for elective cesarean under spinal anesthesia
- Gestational age>38weeks, singleton pregnancy
- Informed consented
Key exclusion criteria (4 listed)
- Patients with pre-eclampsia or diabetes
- Patients with hypertension or cardiac dysfunction
- Disturbance of communication
- Placental abruption
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 |
|---|---|---|
| TEASAlso: Transcutaneous electrical acupoint stimulationElectric stimulation was given through electrode attached to specific acupoints | Other | TEAS Treatment |
| Non-acupoint stimulationElectric stimulation was given through electrode attached to the shoulder | Other | Non-acupoint stimulation |
Primary outcome
Incidence of hypotension
Time frame: During 30min after spinal anesthesia
6 secondary outcomes
Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)
Time frame: During 30min after spinal anesthesia
Lowest SBP and DBP
Time frame: During 30min after spinal anesthesia
Dosage of ephedrine
Time frame: During 30min after spinal anesthesia
postoperative nausea and vomiting(PONV) score
Time frame: During 30min after spinal anesthesia
Incidence of dizzy and dyspnea
Time frame: During 30min after spinal anesthesia
Change of concentration of serum adrenaline and noradrenaline
Time frame: Immediately after TEAS
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 9 Dec 2014.
- Background: PubMed 22309902Sahmeddini MA, Eghbal MH, Khosravi MB, Ghaffaripour S, Janatmakan F, Shokrizade S. Electro-acupuncture stimulation at acupoints reduced the severity of hypotension during anesthesia in patients undergoing liver transplantation. J Acupunct Meridian Stud. 2012 Feb;5(1):11-4. doi: 10.1016/j.jams.2011.11.001. Epub 2011 Dec 7.
- Background: 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.
- Background: PubMed 12893654Syuu Y, Matsubara H, Hosogi S, Suga H. Pressor effect of electroacupuncture on hemorrhagic hypotension. Am J Physiol Regul Integr Comp Physiol. 2003 Dec;285(6):R1446-52. doi: 10.1152/ajpregu.00243.2003. Epub 2003 Jul 31.
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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.
Zhihong LU, MD principal investigator
Air Force Military Medical University, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS and Non-acupoint stimulation in people with Hypotension, run by wangqiang at 2 sites 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 5 inclusion and 4 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (time frame: During 30min after spinal anesthesia). 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 NCT01930227, which also lists 3 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 9 Dec 2014.