Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis

Mahmoud Rashad Ahmed

Status and phase: Enrolling; Phase 4

Conditions: Continuous Spinal Anesthesia; General Anesthesia; Sepsis

Treatments: Drug: General anesthesia; Drug: Continuous spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05897151

35987/10/22

Details and patient eligibility

About

The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient.

Full description

Hemodynamic instability due to high block largely limits the use of conventional dose spinal anesthesia in high-risk septic patients. Hypotension is more common, and also more hazardous, in septic patients, as they may have decreased physiological reserve and compromised blood supply to various vital organs. A smaller dose of local anesthetic reduces the severity and incidence of hypotension during spinal anesthesia.

Enrollment: 110 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Continuous spinal anesthesia

Experimental group

Description:

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 (main arterial pressure \< 70 or main 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.

Treatment:

Drug: Continuous spinal anesthesia

General anesthesia

Active Comparator group

Description:

After establishing of ASA monitoring, a wide bore cannula (18Gague) 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.

Treatment:

Drug: General anesthesia