Hypotension During Surgery
Conditions
Keywords
transcutaneous electrical acupoint stimulation, spinal anesthesia, hypotension
Brief summary
The parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. Acupuncture was reported to treat hypotension both in human and animal studies. Possible mechanisms include modulating cardiovascular and sympathetic system. In this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (TEAS) on hypotension in parturients undergoing cesarean section.
Interventions
OTHERhigh frequency acupoint stimulation
electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given
OTHERlow frequency acupoint stimulation
electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given
OTHERelectrodes attached
electrodes are attached to area of acupoints
Sponsors
Zhihong LU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years * American Society of Anesthesiologists physical status Ⅰ-Ⅱ * singleton pregnancy * full-term gestation (≥38 weeks)
Exclusion criteria
* Parturients suffering from preeclampsia * Parturients with hypertension, diabetes, or cardiac dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of hypotension by 30 minutes after spinal anesthesia | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or \<90 mm Hg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score at 1 minute | 1minute after birth | Apgar score of the neonates at 1minute after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. |
| lowest systolic blood pressure during 30 minutes after spinal anesthesia | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | — |
| dose of ephedrine | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | hypotension is treated with ephedrine in increments of 10 mg every 2 minutes |
| nausea and vomiting score | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | The presence of nausea and vomiting is measured on a 3-point scale of 1, 2, and 3, indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively. |
| incidence of dizzy | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | — |
| incidence of apnea | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | — |
| incidence of chest congestion | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | — |
| dose of atropine | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine |
Countries
China
Outcome results
None listed