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

Hypotension Clinical Trial

— THSAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930227
• Other study ID #: XJH-A-2013-08-1
• 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

• Hypotension

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