Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis

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

Detailed Description
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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.

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

Conditions
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Sepsis, Continuous Spinal Anesthesia, General Anesthesia

Intervention / Treatment
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* Drug: Continuous spinal anesthesia
* Drug: General anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous spinal anesthesia<br>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. | Drug: Continuous spinal anesthesia<br>* 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.<br>|
| Active Comparator: General anesthesia<br>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. | Drug: General anesthesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Patients' mortality during the first 28 day after surgery | 28 Days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Heart Rate | Heart Rate: pre induction (base line), just after induction then at 1min, 5min,10min, 15min, 30min,1 hour after induction, at the end of the surgery and 2 hours postoperative | UP to 2 hours postoperative | 
| Changes of Invasive Blood Pressure | Invasive Blood Pressure: pre induction, just after induction then at 1min, 5min,10min ,15min, 30min ,1 hour after induction , at the end of the surgery and 2 hours postoperative | UP to 2 hours postoperative |