NCT03912688

Brief Summary

Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

February 12, 2019

Last Update Submit

April 10, 2019

Conditions

AnesthesiaPain

Outcome Measures

Primary Outcomes (1)

  • consumption of remifentanil

    from start of anesthesia to extubation, on average 2 hours

Secondary Outcomes (8)

  • time to recall

    from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average

  • time to extubation

    from end of remifentanil infusion to extubation,approximately 10 minutes on average

  • respiratory depression

    end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes

  • nausea and vomiting

    end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes

  • visual analogue scale of pain

    end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes

  • +3 more secondary outcomes

Study Arms (3)

single acupoint stimulation

EXPERIMENTAL
Device: acupoint stimulationDevice: single acupoint

dual acupoints stimulation

EXPERIMENTAL
Device: acupoint stimulationDevice: dual acupoints

no stimulation

NO INTERVENTION

Interventions

acupoint stimulationDEVICE
dual acupoints stimulationsingle acupoint stimulation
single acupointDEVICE
single acupoint stimulation
dual acupointsDEVICE
dual acupoints stimulation

Eligibility Criteria

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

You may qualify if:

  • to 65 yrs
  • body mass index (BMI) of 18 to 30 kg/m2
  • elective radical mastectomy under general anaesthesia

You may not qualify if:

  • contradictions to TEAS
  • difficulties in communication
  • histories of general anaesthesia
  • drug or alcohol abuse or addiction
  • cardiac dysfunction or severe hypertension
  • confirmed hepatic dysfunction and renal impairment
  • the participants recruited into other clinical trials during last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kuhn LA. Editorial: Acupuncture anesthesia for open heart surgery. Am J Cardiol. 1974 Aug;34(2):254-5. doi: 10.1016/0002-9149(74)90207-0. No abstract available.

    PMID: 4843161BACKGROUND

  • Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.

    PMID: 26170347RESULT

  • Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.

    PMID: 24576720RESULT

  • Yan B, Li K, Xu J, Wang W, Li K, Liu H, Shan B, Tang X. Acupoint-specific fMRI patterns in human brain. Neurosci Lett. 2005 Aug 5;383(3):236-40. doi: 10.1016/j.neulet.2005.04.021.

    PMID: 15876491RESULT

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Points

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MeridiansAcupuncture TherapyComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Interventions were performed by a designated investigator who was not involved in the anaesthesia or the follow-up. The stimulator was placed in an opaque box to blind the surgical team and the anesthesiologists to the group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 12, 2019

First Posted

April 11, 2019

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 11, 2019

Record last verified: 2019-04