Clinical trial NCT02533388: Effects of TEAS on Stress Response During Extubation of General Anesthesia in Elderly Patients
Official title: Effects of Transcutaneous Electrical Acupoint Stimulation on the Stress Response During Extubation After General Anesthesia in Elderly Patients Undergoing Elective Supratentorial Craniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: transcutaneous electrical acupoint stimulation
stress response
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Non-invasive arterial blood pressure
timeFrame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
measure: Change in plasma concentrations of epinephrine
timeFrame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
measure: Change in mean arterial blood pressure
timeFrame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
measure: Change in heart rate
timeFrame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
measure: Change in norepinephrine
timeFrame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
measure: Change in cortisol
timeFrame: 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:
measure: Postoperative quality of recovery assessed by Quality of Recovery-40 questionnaire(QoR-40)
timeFrame: From discontinuation of anaesthetic drugs to 24 h after surgery
measure: the time to extubation,the time to reorientation
timeFrame: From discontinuation of anaesthetic drugs to 24 h after surgery
measure: the quality of extubation was evaluated by a 5-point Extubation Quality Score
timeFrame: From discontinuation of anaesthetic drugs to 24 h after surgery
measure: The total amount of remifentanil that used throughout the surgery
timeFrame: From discontinuation of anaesthetic drugs to 24 h after surgery
measure: The total amount of propofol that used throughout the surgery
timeFrame: From discontinuation of anaesthetic drugs to 24 h after surgery
measure: Postoperative complications,like cough,agitation,nausea and vomiting
timeFrame: From discontinuation of anaesthetic drugs to 24 h after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing hospital of China medical university
state: Liaoning
Study officials:
affiliation: professor
name: Junchao Zhu, doctor
role: STUDY_DIRECTOR
References: