Back to resultsContinuous Spinal Anesthesia Versus General Anesthesia in Sepsis
Primary Purpose
Sepsis, Continuous Spinal Anesthesia, General Anesthesia
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Continuous spinal anesthesia
General anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
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.
Sites / Locations
- Tanta University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Continuous spinal anesthesia
General anesthesia
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mortality rate
Patients' mortality during the first 28 day after surgery
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05897151
Brief Title
Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis
Official Title
Comparative Study Between Continuous Spinal Anesthesia Versus General Anesthesia in Patients With Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud Rashad Ahmed
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Continuous Spinal Anesthesia, General Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous spinal anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Continuous spinal anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
General anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality rate
Description
Patients' mortality during the first 28 day after surgery
Time Frame
28 Days postoperative
Secondary Outcome Measure Information:
Title
Changes of Heart Rate
Description
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
Time Frame
UP to 2 hours postoperative
Title
Changes of Invasive Blood Pressure
Description
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
Time Frame
UP to 2 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud R Ahmed, M.B.B.CH
Phone
+20 102 432 0926
Email
mahmoud162104_pg@med.tanta.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud R Ahmed
Phone
+20 102 432 0926
Email
mahmoud162104_pg@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
Elgharbia
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud R Ahmed, MBBCh
Phone
+20 102 432 0926
Email
mahmoud162104_pg@med.tanta.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis
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