Clinical trial

Treatment of Sympathetic Blockade During Spinal Anesthesia in Cesarian Section Patients With Low-dose, Slow-administered Preemptive Atropine

Name
BAIBU-Anesthesia-AA-03
Description
The most common side effect in cesarean section surgeries performed under spinal anesthesia is hypotension, which is seen in over 80% and can cause significant morbidity for the mother and fetus. This side effect results from the sympathetic blocking effect, which also causes bradycardia. A combined approach is supported in the prevention and treatment of hypotension, which recommends adequate fluid support, low-dose spinal anesthesia, and appropriate vasopressor (such as ephedrine, and phenylephrine) and, if bradycardia develops, the use of atropine as a parasympatholytic agent. In this study, the investigators planned to investigate the possible benefits of preemptive administration of atropine, the dose of which is calculated in proportion to the patient's weight, as soon as a 10% decrease in heart rate is detected, in order to balance the sympathetic blockade due to spinal anesthesia in cesarean section operations.
Trial arms
Trial start
2023-07-19
Estimated PCD
2023-10-10
Trial end
2023-10-10
Status
Completed
Phase
Early phase I
Treatment
Slow dose preemptive Atropine
it will planned to administer 0.4 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia)
Arms:
Preemptive Atropine Group
Other names:
Atropine
Ephedrine
For sympathetic blockade (SBP\<90) developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine was used and repeated if necessary.
Arms:
Efedrine Group
Size
60
Primary endpoint
Heart rate
1. minunte after spinal block
Heart rate
4. minute after spinal block
Heart rate
7. minute after spinal block
Heart rate
9. minute after spinal block
Heart rate
12. minute after spinal block
Heart rate
15. minute after spinal block
Systolic Blood pressure
1. minute after spinal block
Systolic Blood pressure
4. minute after spinal block
Systolic Blood pressure
7. minute after spinal block
Systolic Blood pressure
9. minute after spinal block
Systolic Blood pressure
12. minute after spinal block
Systolic Blood pressure
15. minute after spinal block
Mean Blood Pressure
1. minute after spinal block
Mean Blood Pressure
4. minute after spinal block
Mean Blood Pressure
7. minute after spinal block
Mean Blood Pressure
9. minute after spinal block
Mean Blood Pressure
12. minute after spinal block
Mean Blood Pressure
15. minute after spinal block
Efedrine Consumption
1. minute after spinal block
Efedrine Consumption
4. minute after spinal block
Efedrine Consumption
7. minute after spinal block
Efedrine Consumption
9. minute after spinal block
Efedrine Consumption
12. minute after spinal block
Efedrine Consumption
15. minute after spinal block
Atropine Consumption
1. minute after spinal block
Atropine Consumption
4. minute after spinal block
Atropine Consumption
7. minute after spinal block
Atropine Consumption
9. minute after spinal block
Atropine Consumption
12. minute after spinal block
Atropine Consumption
15. minute after spinal block
Eligibility criteria
Inclusion Criteria: ASA Ι-ΙΙ Ages 18-40 Weight 55-105 kg Height 150-175 cm Exclusion Criteria: Who does not require drug administration with fluid therapy Whose hemodynamic changes are within an acceptable range Diabetes COPD Hypertension BMI\>34 Preeclampsia/eclampsia Multiple pregnancies Pathology in the fetus Hematological problems such as Rh incompatibility Hypersensitivity to local anesthetics Contraindications to regional anesthesia
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-10-11

1 organization

2 products

4 indications

Product
Atropine
Indication
Pregnancy
Indication
c-section
Indication
Anesthesia
Indication
spinal
Product
Ephedrine