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

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: Completed
• Conditions: Stress
• Intervention / Treatment: Device: Hwato Electronic Acupuncture Treatment Instrument; Device: Placebo

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Shengjing Hospital Of China Medical University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Non-invasive arterial blood pressure	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Postoperative quality of recovery assessed by Quality of Recovery-40 questionnaire(QoR-40)		From discontinuation of anaesthetic drugs to 24 h after surgery
the time to extubation,the time to reorientation		From discontinuation of anaesthetic drugs to 24 h after surgery
the quality of extubation was evaluated by a 5-point Extubation Quality Score		From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of remifentanil that used throughout the surgery		From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of propofol that used throughout the surgery		From discontinuation of anaesthetic drugs to 24 h after surgery
Postoperative complications,like cough,agitation,nausea and vomiting	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

• Sponsor: Shengjing Hospital
• Investigators: Study Director: Junchao Zhu, doctor, PROFESSOR

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: August 22, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: stress response; transcutaneous electrical acupoint stimulation
• Other Study ID Numbers: TEAS on stress