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Clinical trial

Effect of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Pressure in Obese Pregnant Patients Undergoing Cesarean Section

ID
Name
168/23
Description
Evaluates the effect of hyperbaric subarachnoid bupivacaine at doses of 5 mg vs 10 mg on mean arterial pressure in obese pregnant patients undergoing cesarean section
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-10-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
5mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg
Arms:
5mg bupivacaine
Other names:
hyperbaric bupivacaine 1ml, bupivacaine/Dextrose 1ml
10mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10 mg
Arms:
10mg bupivacaine
Other names:
hyperbaric bupivacaine 2ml, bupivacaine/Dextrose 2ml
Size
106
Primary endpoint
Assess the mean blood pressure
3 hour
Determine the effects on the heart rate
3 hour
Determine the effects on the O2 saturation
3 hour
Eligibility criteria
Inclusion Criteria: * Pregnancy ≥37 weeks gestation with single fetus * Body mass index (BMI) ≥ 30 kg/m2 * Indication of termination of pregnancy via abdominal caesarean section * Indication of subarachnoid neuraxial block under mixed technique * Signing of consent under information Exclusion Criteria: * Allergy to local anesthetics * Psychiatric treatment (antidepressants, anxiolytics, antipsychotics) * Addiction to any type of drug * Liver, renal, pulmonary or cardiac disease * High blood pressure * Type I, II and gestational diabetes * Diagnostic of non-calming fetal state
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical trial open controlled parallel randomized simple', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'You do not know the dose of bupivacaine you receive', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 106, 'type': 'ESTIMATED'}}
Updated at
2023-09-29

1 organization

1 product

2 indications

Organization
Hospital Civil de Guadalajara
Product
Bupivacaine
Indication
Anesthesia
Indication
Obstetric Anesthesia Problems