Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis

NCT05897151 | Unknown Phase 4

• 1 other identifier: 35987/10/22
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis; Continuous Spinal Anesthesia; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  Patients' mortality during the first 28 day after surgery

  28 Days postoperative

Secondary Outcomes (2)

• Changes of Heart Rate

  UP to 2 hours postoperative

• Changes of Invasive Blood Pressure

  UP to 2 hours postoperative

Study Arms (2)

Continuous spinal anesthesia

EXPERIMENTAL

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

General anesthesia

ACTIVE COMPARATOR

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

Interventions

Continuous spinal anesthesia DRUG

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.

Continuous spinal anesthesia

General anesthesia DRUG

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.

General anesthesia

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahmoud Rashad Ahmed: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Elgharbia, 31511, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Mahmoud R Ahmed, M.B.B.CH

CONTACT

+20 102 432 0926; mahmoud162104_pg@med.tanta.edu.eg

Mahmoud R Ahmed

CONTACT

+20 102 432 0926; mahmoud162104_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 9, 2023
• Study Start: June 10, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From one year after study completion.
• Access Criteria: The data will be available upon reasonable request from the corresponding author

Locations

EG (1)