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Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients

NCT ID: NCT01930227

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to compare the effect of TEAS on hypotension after spinal anesthesia in patients undergoing cesarean section

Detailed Description

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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

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Hypotension

Keywords

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hypotension spinal anesthesia cesarean

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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TEAS Treatment

Patients were given 30min of TEAS at PC6 after spinal anesthesia

Group Type EXPERIMENTAL

TEAS

Intervention Type OTHER

Electric stimulation was given through electrode attached to specific acupoints

Non-acupoint stimulation

Patients were given 30min of electrical stimulation at shoulder after spinal anesthesia

Group Type SHAM_COMPARATOR

Non-acupoint stimulation

Intervention Type OTHER

Electric stimulation was given through electrode attached to the shoulder

Control

No stimulation was given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TEAS

Electric stimulation was given through electrode attached to specific acupoints

Intervention Type OTHER

Non-acupoint stimulation

Electric stimulation was given through electrode attached to the shoulder

Intervention Type OTHER

Other Intervention Names

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Transcutaneous electrical acupoint stimulation

Eligibility Criteria

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Inclusion Criteria

* Age\>18yrs
* American Society of Anesthesiologists(ASA) status 1-2
* Scheduled for elective cesarean under spinal anesthesia
* Gestational age\>38weeks, singleton pregnancy
* Informed consented

Exclusion Criteria

* Patients with pre-eclampsia or diabetes
* Patients with hypertension or cardiac dysfunction
* Disturbance of communication
* Placental abruption
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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wangqiang

OTHER

Sponsor Role lead

Responsible Party

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wangqiang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhihong LU, MD

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

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Women and Children's Hospital of Shaanxi Province

Xi'an, Shaanxi, China

Site Status

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 22309902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17959591 (View on PubMed)

Syuu 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.

Reference Type BACKGROUND
PMID: 12893654 (View on PubMed)

Other Identifiers

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XJH-A-2013-08-1

Identifier Type: -

Identifier Source: org_study_id