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Clinical trial

Comparative Study Between Continuous Spinal Anesthesia Versus General Anesthesia in Patients With Sepsis

ID
Name
35987/10/22
Description
The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient.
Trial arms
Trial start
2023-06-10
Estimated PCD
2023-11-30
Trial end
2023-11-30
Status
Recruiting
Phase
Early phase I
Treatment
Continuous spinal anesthesia
Preservative free 0.5% Hyperbaric bupivacaine (AstraZeneca) 5mg + 25mcg fentanyl for the initial dose will be followed by top up doses of 2.5 mg boluses of 0.5% Hyperbaric bupivacaine every 10 minutes until the desired block height is obtained considering patient hemodynamics. Norepinephrine starting. dose 0.01 micg/kg/min will be ready for both groups if needed (Mean arterial pressure \< 70 or Mean arterial pressure decreased more than 20% of preoperative value). The infusion will be through a wide bore Intravenous line. The dose will be titrated up or down according to the patient hemodynamics.
Arms:
Continuous spinal anesthesia
General anesthesia
After establishing of ASA monitoring, a wide bore cannula (18 G) will be inserted. Induction will be done by fentanyl ( 2 mcg/kg ) , titrating dose of propofol according to patient hemodynamic response and atracurium ( 0.5 mg/kg ) to facilitate tracheal intubation maintaining End tidal Co2 between 30-40 mmHg.
Arms:
General anesthesia
Size
110
Primary endpoint
Mortality rate
28 Days postoperative
Eligibility criteria
Inclusion Criteria: * Patients over 21 years old * American Society of Anesthesiologists (III, IV) diagnosed with sepsis (Sequential Organ Failure Assessment (SOFA) score ≥ 7) * Hemodynamically stable and not on vasopressor due to lower limb pathology candidate for spinal anesthesia to drain source of infection. Exclusion Criteria: * Patients with known hypersensitivity to local anesthesia. * Infection at the site of injection. * Coagulopathy. * Septic shock. * Increase of intracranial pressure. * Severe deformity of the spinal column.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2023-06-13

1 organization

2 products

3 indications

Organization
Mahmoud Rashad Ahmed
Product
Continuous spinal anesthesia
Indication
Sepsis
Indication
Continuous Spinal Anesthesia
Indication
General Anesthesia
Product
General anesthesia