Anesthesia, Post-induction Hypotension (PIH), Transcutaneous Electrical Acupoint Stimulation
Conditions
Keywords
transcutaneous electrical acupoint stimulation, frequency, hemodynamic stability
Brief summary
From 15 minutes before to 15 minutes after anesthesia, Transcutaneous Electrical Acupoint Stimulation(TEAS) at different frequencies will be applied at Neiguan and Jian Shi. The changes in blood pressure during the anesthesia induction period will be compared among the high-frequency group ,the low-frequency group and the control group to explore the better frequency to reduce the incidence of post-induction hypotension(PIH) in the elderly.
Interventions
electrical acupoint stimulation are administered at Neiguan and Jian Shi. The stimulation starts at 15 minutes before anesthesia induction and ends at 15 minutes after anesthesia induction.
OTHERelectrodes pasted
Electrodes are pasted at Neiguan and Jianshi
The frequency of electrical stimulation is 100Hz
OTHERlow-frequency electrical stimulation
The frequency of electrical stimulation is 2Hz
Sponsors
Zhihong LU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged over 65 yrs old * elective abdominal surgery under general anesthesia * written infromed consent
Exclusion criteria
* American society of anesthesiologists status over 3 * New York Heart Association (NYHA) Functional Classification≥Ⅲ * severe arrhythmia leading to hemodynamic instability * uncontrolled diabetes * hypertension patients stratified as very high risk according to cardiovascular risk classification * people who have TEAS contraindications such as local acupoint skin injury or infection and implanted cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of hypotension | from start of anesthesia induction to 15 minutes after induction | Hypotension is defined as a Mean arterial pressure (MAP) reduction of more than 20% from baseline or a MAP less than 65 mm Hg for at least 30 seconds. The baseline MAP is measured during the 5 minutes before start of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline. | from start of induction to 15 minutes after induction | The area under the curve (AUC) below baseline mean arterial pressure (MAP) is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at the i-th minute (i = 1…15), and ΔX is the time interval between two measurements. |
| The dosage of vasoactive drugs | from start of induction to 15 minutes after induction | Any MAP drop by more than 20% from baseline or a MAP less than 65 mm Hg for at least 1 minute within the first 15 minutes after general anesthesia induction triggered the administration of norepinephrine boluses (5 μg). If hypotension persisted after 2 boluses, a norepinephrine infusion (0.02-0.3 μg/kg/min) was initiated and continued until the MAP became stable and reached 65 mm Hg or higher. If hypotension reoccurred, 2 boluses of norepinephrine were repeated. |
| lowest MAP | from start of induction to 15 minutes after induction | — |
| standard deviation of R-R intervals (SDRR) | from start of induction to 15 minutes after induction | assessed from the electrocardiography, key index of heart rate variability (HRV) |
| ratio of low-frequency HRV/high-frequency HRV (LF/HF ratio) | from start of induction to 15 minutes after induction | assessed from the electrocardiography,High-frequency HRV (HF-HRV) at 0.15-0.4 Hz and low-frequency HRV (LF-HRV) at 0.04-0.15 Hz |
| major in-hospital complication incidence within 5 postoperative days | from start of anesthesia to the 5 days after anesthesia | major in-hospital complication incidence within 5 postoperative days |
Contacts
CONTACTZhihong Lu
Outcome results
None listed