Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis

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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; General Anesthesia; Continuous Spinal Anesthesia
• Intervention / Treatment: Drug: Continuous spinal anesthesia; Drug: General anesthesia

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mahmoud R Ahmed, M.B.B.CH; Phone Number: +20 102 432 0926; Email: mahmoud162104_pg@med.tanta.edu.eg
• Study Contact Backup: Name: Mahmoud R Ahmed; Phone Number: +20 102 432 0926; Email: mahmoud162104_pg@med.tanta.edu.eg

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt, 31511
      • Recruiting
      • Tanta University hospitals
      • Contact: Mahmoud R Ahmed, MBBCh; Phone Number: +20 102 432 0926; Email: mahmoud162104_pg@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahmoud Rashad Ahmed

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 35987/10/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author from one year after study completion.
• IPD Sharing Time Frame: From one year after study completion.
• IPD Sharing Access Criteria: The data will be available upon reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No