Clinical trial NCT01930227: Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Keywords: hypotension
spinal anesthesia
cesarean
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hypotension
timeFrame: During 30min after spinal anesthesia
Secondary outcomes:
measure: Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)
timeFrame: During 30min after spinal anesthesia
measure: Lowest SBP and DBP
timeFrame: During 30min after spinal anesthesia
measure: Dosage of ephedrine
timeFrame: During 30min after spinal anesthesia
measure: postoperative nausea and vomiting(PONV) score
timeFrame: During 30min after spinal anesthesia
measure: Incidence of dizzy and dyspnea
timeFrame: During 30min after spinal anesthesia
measure: Change of concentration of serum adrenaline and noradrenaline
timeFrame: Immediately after TEAS
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Women and Children's Hospital of Shaanxi Province
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Zhihong LU, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1152/ajpregu.00243.2003. Epub 2003 Jul 31.