TEAS to Reduce Propofol Consumption During General Anesthesia (TOP)

November 8, 2022 updated by: Zhihong LU, Air Force Military Medical University, China

Effect of Transcutaneous Electrical Acupoint Stimulation on Propofol Consumption During General Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous acupoint stimulation
Electrical stimulation was given through electrodes attached to skin at Ximen and Shenmen acupoint during anesthesia
Other: acupoint stimulation
stimulation was given at acupoints
Other: electrodes attached
electrode were attached to skin
Placebo Comparator: Non-acupoint stimulation
Electrical stimulation was given through electrodes attached to skin at shoulder (non-acupoint) during anesthesia
Other: electrodes attached
electrode were attached to skin
Other: non-acupoint stimulation
stimulation was given at non-acupoints
Sham Comparator: Control
patients were with electrodes attached but no stimulation was given
Other: electrodes attached
electrode were attached to skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
propofol consumption
Time Frame: from induction to the end of surgery,at an average of 1 hour
from induction to the end of surgery,at an average of 1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
time to awake
Time Frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
time to extubation
Time Frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
effect site concentration of propofol at awake
Time Frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
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
Time Frame: from end of surgery to discharge from post anesthesia care unit, at an average of 1 hour
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
Time Frame: 30min after surgery
30min after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Zhihong LU, PhD, Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2015

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

December 29, 2017

Study Registration Dates

First Submitted

December 7, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • XJH-A-2014-6-25-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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