NCT01930227

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

August 24, 2013

Last Update Submit

December 7, 2014

Conditions

Hypotension

Keywords

hypotensionspinal anesthesiacesarean

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypotension

    During 30min after spinal anesthesia

Secondary Outcomes (6)

  • Average systemic blood pressure(SBP) and diastolic blood pressure(DBP)

    During 30min after spinal anesthesia

  • Lowest SBP and DBP

    During 30min after spinal anesthesia

  • Dosage of ephedrine

    During 30min after spinal anesthesia

  • postoperative nausea and vomiting(PONV) score

    During 30min after spinal anesthesia

  • Incidence of dizzy and dyspnea

    During 30min after spinal anesthesia

  • +1 more secondary outcomes

Study Arms (3)

TEAS Treatment

EXPERIMENTAL

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

Other: TEAS

Non-acupoint stimulation

SHAM COMPARATOR

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

Other: Non-acupoint stimulation

Control

NO INTERVENTION

No stimulation was given

Interventions

TEASOTHER

Electric stimulation was given through electrode attached to specific acupoints

Also known as: Transcutaneous electrical acupoint stimulation
TEAS Treatment
Non-acupoint stimulationOTHER

Electric stimulation was given through electrode attached to the shoulder

Non-acupoint stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with pre-eclampsia or diabetes
  • Patients with hypertension or cardiac dysfunction
  • Disturbance of communication
  • Placental abruption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women and Children's Hospital of Shaanxi Province

Xi'an, Shaanxi, 710000, China

Location

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

  • 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.

    PMID: 22309902BACKGROUND

  • 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.

    PMID: 17959591BACKGROUND

  • 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.

    PMID: 12893654BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Zhihong LU, MD

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2013

First Posted

August 28, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

CN(2)