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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stress

Intervention / Treatment
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* Device: Hwato Electronic Acupuncture Treatment Instrument
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical acupoint stimulation<br>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<br>* 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.<br>|
| Sham Comparator: Sham stimulation<br>Sham stimulation only connected to the apparatus, but electronic stimulation was not applied. | Device: Placebo<br>* The patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous electrical acupoint stimulation, stress response