Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis

Phase 4

Recruiting

• Conditions: Sepsis; Continuous Spinal Anesthesia; General Anesthesia
• Interventions: Drug: Continuous spinal anesthesia; Drug: General anesthesia

• Registration Number: NCT05897151
• Lead Sponsor: Mahmoud Rashad Ahmed

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.

Study Timeline

• Study First Submitted: 2023-05-07
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-09
• Study Start: 2023-06-10
• Last Update Submitted: 2023-06-10
• Last Update Posted: 2023-06-13
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous spinal anesthesia	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 (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.
General anesthesia	General anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Mortality rate	28 Days postoperative	Patients' mortality during the first 28 day after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Elgharbia, Egypt