Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897151
• Other study ID #: 35987/10/22
• Status: Recruiting
• Phase: Phase 4
• Start date: June 10, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2023
• Source: Tanta University
• Contact: Mahmoud R Ahmed, M.B.B.CH
• Phone: +20 102 432 0926
• Email: mahmoud162104_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia
• Sepsis
• Toxemia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Mahmoud Rashad Ahmed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Patients' mortality during the first 28 day after surgery	28 Days postoperative
Secondary	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
Secondary	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