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
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan and Jian Shi. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged over 65 yrs old
scheduled for surgery under general anesthesia
Disqualifiers
American society of anesthesiologists status over 3
severe cardiac or respiratory dysfunction
severe cardiac arrhythmia
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
84 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 1 minute. 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: