Frequency of Electrical Acupoint Stimulation on Hypotension During Induction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorZhihong LU
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged over 65 yrs old
elective abdominal surgery under general anesthesia
written infromed consent
Disqualifiers
American society of anesthesiologists status over 3
New York Heart Association (NYHA) Functional Classification≥Ⅲ
severe arrhythmia leading to hemodynamic instability
uncontrolled diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
electrical acupoint stimulation
Other interventionelectrical 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.
electrodes pasted
Other interventionElectrodes are pasted at Neiguan and Jianshi
high-frequency electrical stimulation
Other interventionThe frequency of electrical stimulation is 100Hz
low-frequency electrical stimulation
Other interventionThe frequency of electrical stimulation is 2Hz
Treatment groups
204 Participants
are divided into 3 treatment groupsGroup A: High-frequencyExperimental treatment 3 interventions
Group B: Low-frequencyExperimental treatment 3 interventions
Group C: No stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
incidence of hypotension
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
Time frame
from start of anesthesia induction to 15 minutes after inductionSecondary outcomes
1
The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.
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.
Time frame
from start of induction to 15 minutes after induction2
The dosage of vasoactive drugs
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.
Time frame
from start of induction to 15 minutes after induction3
lowest MAP
Time frame
from start of induction to 15 minutes after induction4
standard deviation of R-R intervals (SDRR)
assessed from the electrocardiography, key index of heart rate variability (HRV)
Time frame
from start of induction to 15 minutes after inductionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhihong LU
Lead sponsor
Air Force Military Medical University, China
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: