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

NCT02533388 | Completed DMC

• 1 other identifier: TEAS on stress
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress

Keywords

transcutaneous electrical acupoint stimulation; stress response

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• 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

Study Arms (2)

Electrical acupoint stimulation

EXPERIMENTAL

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

Sham stimulation

SHAM COMPARATOR

Sham stimulation only connected to the apparatus, but electronic stimulation was not applied.

Device: Placebo

Interventions

Hwato Electronic Acupuncture Treatment Instrument DEVICE

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.

Electrical acupoint stimulation

Placebo DEVICE

The patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied.

Sham stimulation

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing hospital of China medical university

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Junchao Zhu, doctor

  professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: August 26, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

CN (1)