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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01930227
Other study ID # XJH-A-2013-08-1
Secondary ID
Status Completed
Phase N/A
First received August 24, 2013
Last updated December 7, 2014
Start date September 2013
Est. completion date August 2014

Study information

Verified date December 2014
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
TEAS
Electric stimulation was given through electrode attached to specific acupoints
Non-acupoint stimulation
Electric stimulation was given through electrode attached to the shoulder

Locations

Country Name City State
China Women and Children's Hospital of Shaanxi Province Xi'an Shaanxi
China Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
wangqiang

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Epub 2007 Oct 24. — View Citation

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. — View Citation

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. Epub 2003 Jul 31. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of hypotension During 30min after spinal anesthesia No
Secondary Average systemic blood pressure(SBP) and diastolic blood pressure(DBP) During 30min after spinal anesthesia No
Secondary Lowest SBP and DBP During 30min after spinal anesthesia No
Secondary Dosage of ephedrine During 30min after spinal anesthesia No
Secondary postoperative nausea and vomiting(PONV) score During 30min after spinal anesthesia No
Secondary Incidence of dizzy and dyspnea During 30min after spinal anesthesia No
Secondary Change of concentration of serum adrenaline and noradrenaline Immediately after TEAS No
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