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NCT Number: NCT02533388

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

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.

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Key information

Conditions

Stress Fractures, Bone Fractures, Stress Wounds and Injuries

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing hospital of China medical university

Shenyang, Liaoning, 110000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

PLACEBO

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. the time to extubation,the time to reorientation

    Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery

  3. 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

  4. The total amount of remifentanil that used throughout the surgery

    Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery

  5. The total amount of propofol that used throughout the surgery

    Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery

  6. 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.

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 26, 2015
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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