SepsisPhase 4NCT05897151
Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis
A Phase 4 study testing Continuous spinal anesthesia and General anesthesia in people with Sepsis and Continuous Spinal Anesthesia, run by Mahmoud Rashad Ahmed at 1 site in Egypt.
Trial summary
The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sepsis, Continuous Spinal Anesthesia, General Anesthesia
- What is being tested?
- Continuous spinal anesthesia and General anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2023to 30 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Elgharbia, 31511
Mahmoud R Ahmed, MBBCh, +20 102 432 0926, mahmoud162104_pg@med.tanta.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Continuous Spinal Anesthesia, General Anesthesia
- Being tested
- Continuous spinal anesthesia, General anesthesia
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous spinal anesthesiaDrug
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 anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Patients' mortality during the first 28 day after surgery
Measured: 28 Days postoperative
Secondary outcomes (2)
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
Measured: 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
Measured: UP to 2 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start10 Jun 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Rashad Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Rashad Ahmed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897151
- Sponsor's protocol ID
- 35987/10/22
- Status last verified
- Jun 2023
- First submitted
- 7 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author from one year after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Continuous Spinal Anesthesia Versus General Anesthesia in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT05897151
- Acronym / sponsor ID
- 35987/10/22
- Conditions
- Sepsis, Continuous Spinal Anesthesia, General Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mahmoud Rashad AhmedUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous spinal anesthesia | Experimental | Drug: Continuous spinal anesthesiaPreservative 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. |
| General anesthesia | Active comparator | Drug: General anesthesiaAfter 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients with known hypersensitivity to local anesthesia.
- Infection at the site of injection.
- Coagulopathy.
- Septic shock.
- Increase of intracranial pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous spinal anesthesiaPreservative 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. | Drug | Continuous spinal anesthesia |
| General anesthesiaAfter 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. | Drug | General anesthesia |
Primary outcome
Mortality rate
Time frame: 28 Days postoperative
Patients' mortality during the first 28 day after surgery
2 secondary outcomes
Changes of Heart Rate
Time frame: UP to 2 hours postoperative
Changes of Invasive Blood Pressure
Time frame: UP to 2 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author from one year after study completion.
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous spinal anesthesia and General anesthesia in people with Sepsis and Continuous Spinal Anesthesia, run by Mahmoud Rashad Ahmed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud R Ahmed, M.B.B.CH (+20 102 432 0926, mahmoud162104_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 28 Days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.