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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05897151
Other study ID # 35987/10/22
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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