Clinical trial
Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery: A Randomized Controlled Trial
Name
48-2022
Description
The aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery.
Trial arms
Trial start
2022-05-01
Estimated PCD
2023-07-01
Trial end
2023-07-01
Status
Completed
Treatment
Group A (hyperbaric bupivacaine)
Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution
Arms:
Group A (hyperbaric bupivacaine)
Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)
Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution
Arms:
Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)
Size
50
Primary endpoint
Incidence of hypotension
3 hours post-injection
Eligibility criteria
Inclusion Criteria:
* Age between 18-65 years old.
* Both sexes.
* American Society of Anaesthesia (ASA) I to II.
* Undergoing lower abdominal or urological surgery under spinal anesthesia
Exclusion Criteria:
* Allergy to amide.
* Patients with a significant history of substance abuse.
* Patients with diabetes mellitus, neurological or cardiovascular diseases.
* Patients with neuromuscular diseases.
* Pregnant patients.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-09-22
1 organization
2 products
4 indications
Organization
Helwan UniversityProduct
Group AIndication
Spinal AnesthesiaIndication
Hyperbaric BupivacaineIndication
BupivacaineIndication
Lower Abdominal Surgery