NCT02314650

Brief Summary

The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

December 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

August 25, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.3 years

First QC Date

December 7, 2014

Last Update Submit

November 8, 2022

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • propofol consumption

    from induction to the end of surgery,at an average of 1 hour

Secondary Outcomes (5)

  • time to awake

    from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes

  • time to extubation

    from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes

  • effect site concentration of propofol at awake

    from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes

  • highest sedation score during stay at postanesthesia care unit

    from end of surgery to discharge from post anesthesia care unit, at an average of 1 hour

  • nausea and vomiting during stay at postanesthesia care unit

    30min after surgery

Study Arms (3)

Transcutaneous acupoint stimulation

EXPERIMENTAL

Electrical stimulation was given through electrodes attached to skin at Ximen and Shenmen acupoint during anesthesia

Other: acupoint stimulationOther: electrodes attached

Non-acupoint stimulation

PLACEBO COMPARATOR

Electrical stimulation was given through electrodes attached to skin at shoulder (non-acupoint) during anesthesia

Other: non-acupoint stimulationOther: electrodes attached

Control

SHAM COMPARATOR

patients were with electrodes attached but no stimulation was given

Other: electrodes attached

Interventions

acupoint stimulationOTHER

stimulation was given at acupoints

Transcutaneous acupoint stimulation
non-acupoint stimulationOTHER

stimulation was given at non-acupoints

Non-acupoint stimulation
electrodes attachedOTHER

electrode were attached to skin

ControlNon-acupoint stimulationTranscutaneous acupoint stimulation

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing minor surgeries including laparoscopic surgery and breast surgery under general anesthesia
  • Patients with written informed consent

You may not qualify if:

  • Patients with difficulty to communicate,including psychiatric disorder and Alzheimer's disease
  • Patients with drug abuse
  • Patients with disease of central nervous system
  • Patients with renal or hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

  • Fassoulaki A, Paraskeva A, Patris K, Pourgiezi T, Kostopanagiotou G. Pressure applied on the extra 1 acupuncture point reduces bispectral index values and stress in volunteers. Anesth Analg. 2003 Mar;96(3):885-890. doi: 10.1213/01.ANE.0000048713.41657.D3.

    PMID: 12598279RESULT

  • Nayak S, Wenstone R, Jones A, Nolan J, Strong A, Carson J. Surface electrostimulation of acupuncture points for sedation of critically ill patients in the intensive care unit--a pilot study. Acupunct Med. 2008 Mar;26(1):1-7. doi: 10.1136/aim.26.1.1.

    PMID: 18356793RESULT

Study Officials

  • Zhihong LU, PhD

    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
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 11, 2014

Study Start

August 25, 2015

Primary Completion

December 28, 2017

Study Completion

December 29, 2017

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

CN(1)