Continuous Spinal Anesthesia, General Anesthesia, Sepsis
Conditions
Brief summary
The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient.
Detailed 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.
Interventions
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.
DRUGGeneral 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.
Sponsors
Mahmoud Rashad Ahmed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 28 Days postoperative | Patients' mortality during the first 28 day after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Heart Rate | UP to 2 hours postoperative | 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 |
| Changes of Invasive Blood Pressure | UP to 2 hours postoperative | 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 |
Countries
Egypt
Contacts
Primary ContactMahmoud R Ahmed, M.B.B.CH
Backup ContactMahmoud R Ahmed
Outcome results
None listed