Effects of TEAS on Stress Response During Extubation of General Anesthesia in Elderly Patients

March 10, 2017 updated by: Yanchao Yang, Shengjing Hospital

Effects of Transcutaneous Electrical Acupoint Stimulation on the Stress Response During Extubation After General Anesthesia in Elderly Patients Undergoing Elective Supratentorial Craniotomy

Elderly patients have an increased risk of stress responses during extubation after general anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses during extubation after general anaesthesia remains challenging for the anaesthesiologist. In this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly patients who underwent elective supratentorial craniotomy under general anaesthesia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 100 elderly patients scheduled for elective supratentorial craniotomy under propofol-remifentanil total intravenous anaesthesia were randomly divided to either TEAS group (received stimulation at LI4, PC6, LU7, LU5, LI18 and ST9 acupoints, 2/10Hz, 6-15 mA) or Sham group (received no stimulation). The primary outcomes were the haemodynamic parameters and plasma concentrations of epinephrine (E), norepinephrine (NE) and cortisol (Cor). The secondary outcomes were the consumption of remifentanil and propofol, the time from discontinuation of anesthetics to extubation and reorientation, extubation quality score, the quality of postoperative recovery and postoperative complications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Shengjing Hospital of China Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA Ⅱ～Ⅲ
  • aged 60-70years
  • scheduled for elective supratentorial craniotomy under general anaesthesia

Exclusion Criteria:

  • past or current history of cardiovascular and/or cerebrovascular diseases
  • diabetes
  • pre-existing liver, lung or kidney dysfunction
  • psychiatric disorders
  • potentially difficult airway
  • previous acupuncture treatment
  • infection at the stimulus sites

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Electrical acupoint stimulation
Electrical acupoint stimulation at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints, Stimulus frequency was an alternate dense-disperse frequency of 2/10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, which was adjusted to maintain a slight twitching of the regional muscles according to individual maximum tolerance.
Device: Hwato Electronic Acupuncture Treatment Instrument
Thirty minutes prior to the induction of anaesthesia, the patients in the TEAS group started to receive TEAS by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model No.: SDZ-II, Suzhou Medical Appliances Co., Ltd., Suzhou, China) to the right hand, forearm and neck by an experienced acupuncturist at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints. TEAS was peformed with an alternate dense-disperse frequency of 2 and10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, The stimulus continued until 5 min before the end of surgery.
Sham Comparator: Sham stimulation
Sham stimulation only connected to the apparatus, but electronic stimulation was not applied.
Device: Placebo
The patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Non-invasive arterial blood pressure
Time Frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Non-invasive arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in plasma concentrations of epinephrine
Time Frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
plasma concentrations of epinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in mean arterial blood pressure
Time Frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Mean arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in heart rate
Time Frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Heart rate was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in norepinephrine
Time Frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Norepinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in cortisol
Time Frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Cortisol was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative quality of recovery assessed by Quality of Recovery-40 questionnaire(QoR-40)
Time Frame: From discontinuation of anaesthetic drugs to 24 h after surgery
From discontinuation of anaesthetic drugs to 24 h after surgery
the time to extubation,the time to reorientation
Time Frame: From discontinuation of anaesthetic drugs to 24 h after surgery
From discontinuation of anaesthetic drugs to 24 h after surgery
the quality of extubation was evaluated by a 5-point Extubation Quality Score
Time Frame: From discontinuation of anaesthetic drugs to 24 h after surgery
From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of remifentanil that used throughout the surgery
Time Frame: From discontinuation of anaesthetic drugs to 24 h after surgery
From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of propofol that used throughout the surgery
Time Frame: From discontinuation of anaesthetic drugs to 24 h after surgery
From discontinuation of anaesthetic drugs to 24 h after surgery
Postoperative complications,like cough,agitation,nausea and vomiting
Time Frame: From discontinuation of anaesthetic drugs to 24 h after surgery
Cough was assessed using a four-point scale；Agitation was evaluated using the Ricker Sedation-Agitation Scale；Nausea was defined as the patient complained of an unpleasant sensation with the urgency to vomit. Vomiting was defined as the forceful expulsion of gastric contents from the patient's mouth.
From discontinuation of anaesthetic drugs to 24 h after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shengjing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Junchao Zhu, doctor, Professor

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TEAS on stress

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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