Septic ShockPhase 4NCT03251170
Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock
A Phase 4 study testing Ketamine, Fentanyl and Midazolam in people with Septic Shock, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this work is to compare two protocols (ketamine-midazolam versus fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Ketamine, Fentanyl and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2018to 30 Dec 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sepsis patients
- With shock index (heart rate divided by systolic blood pressure) >0.7. or Sepsis patients with norepinephrine infusion.
Who cannot join
- Traumatic brain injury
- Cerebrovascular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine-based Versus Opioid-based for Rapid-sequence Induction of Anesthesia in Patients With Septic Shock
The aim of this work is to compare two protocols (ketamine-midazolam versus fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients
Read the detailed description
Induction of anesthesia in hemodynamically compromised patients is a challenge for every anesthetist. Most of the intravenous induction agents have a negative effect on arterial blood pressure and cardiac output. Theoretically, the "ideal" emergency induction intravenous anesthetic should achieve rapid hypnosis and maintain the hemodynamic stability.
Ketamine has been reported as an induction anesthetic with a sympathomimetic activity. In patients with intact autonomic nervous system ketamine increases heart rate, cardiac output, and arterial blood pressure (ABP). Despite its sympathomimetic activity in hemodynamically stable patients, the hemodynamic response to ketamine in unstable cardiovascular conditions is not clear. No studies to the best of our knowledge compared Ketamine-based and opioid-based protocols in rapid sequence induction of anesthesia in hemodynamically unstable patients.
In this study, patients with severe sepsis or septic shock scheduled for surgery will be assigned to receive either ketamine or fentanyl for induction of anesthesia. After induction of anesthesia, endotracheal tube will be inserted aided by succinyl choline. Invasive blood pressure will be monitored through a transducer connected to arterial catheter. Electrical velocimetry (cardiometry) device will be used for non-invasive monitoring of cardiac output and stroke volume.
- Conditions
- Septic Shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Katalar
Patients will receive :1 mg/Kg ketamine for induction of anesthesia
FentanylDrug
Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia
MidazolamDrug
Also called Dormicum
Patients will receive 0.05 mg/Kg midazolam
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Experimental | This group of patients will receive: 1 mg/Kg ketamine + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance. Receives: Drug: Ketamine; Drug: Midazolam |
| Fentanyl | Active comparator | 2.5 mg/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance. Receives: Drug: Fentanyl; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Mean arterial blood pressure measured by invasive transducer attached to arterial catheter
Measured: 30 minutes after induction of anesthesia
Secondary outcomes (7)
cardiac output
cardiac output measured in litres per minute measured by electrical velocimetry
Measured: 30 minutes after induction of anesthesia
Stroke volume
cardiac stroke volume in milliliters measured by electrical velocimetry
Measured: 30 minutes after induction of anesthesia
heart rate
heart rate measured in beat per minute
Measured: 30 minutes after induction of anesthesia
serum lactate
serum lactate measured in mmol/liter
Measured: 30 minutes after induction of anesthesia
total norepinephrine dose
total dose of norepinephrine measured in micrograms
Measured: 30 minutes after induction of anesthesia
Intra-operative inhalational anesthetic concentration
the concentration of inhalational anesthetic (%)
Measured: 30 minutes
Incidence of post-induction hypotension
The percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia or increasing the dose of vasopressors
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start25 Jan 2018
- Primary completion25 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251170
- Sponsor's protocol ID
- N-12-2018
- Status last verified
- Jan 2020
- First submitted
- 12 Aug 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine-based Versus Opioid-based for Rapid-sequence Induction of Anesthesia in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT03251170
- Acronym / sponsor ID
- N-12-2018
- Conditions
- Septic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 16 Aug 2017 (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 aim of this work is to compare two protocols (ketamine-midazolam versus fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients
Detailed description
Induction of anesthesia in hemodynamically compromised patients is a challenge for every anesthetist. Most of the intravenous induction agents have a negative effect on arterial blood pressure and cardiac output. Theoretically, the "ideal" emergency induction intravenous anesthetic should achieve rapid hypnosis and maintain the hemodynamic stability.
Ketamine has been reported as an induction anesthetic with a sympathomimetic activity. In patients with intact autonomic nervous system ketamine increases heart rate, cardiac output, and arterial blood pressure (ABP). Despite its sympathomimetic activity in hemodynamically stable patients, the hemodynamic response to ketamine in unstable cardiovascular conditions is not clear. No studies to the best of our knowledge compared Ketamine-based and opioid-based protocols in rapid sequence induction of anesthesia in hemodynamically unstable patients.
In this study, patients with severe sepsis or septic shock scheduled for surgery will be assigned to receive either ketamine or fentanyl for induction of anesthesia. After induction of anesthesia, endotracheal tube will be inserted aided by succinyl choline. Invasive blood pressure will be monitored through a transducer connected to arterial catheter. Electrical velocimetry (cardiometry) device will be used for non-invasive monitoring of cardiac output and stroke volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Experimental | Drug: Ketamine, Drug: MidazolamThis group of patients will receive: 1 mg/Kg ketamine + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance. |
| Fentanyl | Active comparator | Drug: Fentanyl, Drug: Midazolam2.5 mg/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sepsis patients
- With shock index (heart rate divided by systolic blood pressure) >0.7. or Sepsis patients with norepinephrine infusion.
Key exclusion criteria (2 listed)
- Traumatic brain injury
- Cerebrovascular disorders
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 |
|---|---|---|
| KetamineAlso: KatalarPatients will receive :1 mg/Kg ketamine for induction of anesthesia | Drug | Ketamine group |
| FentanylPatients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia | Drug | Fentanyl |
| MidazolamAlso: DormicumPatients will receive 0.05 mg/Kg midazolam | Drug | Fentanyl, Ketamine group |
Primary outcome
Mean arterial pressure
Time frame: 30 minutes after induction of anesthesia
Mean arterial blood pressure measured by invasive transducer attached to arterial catheter
7 secondary outcomes
cardiac output
Time frame: 30 minutes after induction of anesthesia
Stroke volume
Time frame: 30 minutes after induction of anesthesia
heart rate
Time frame: 30 minutes after induction of anesthesia
serum lactate
Time frame: 30 minutes after induction of anesthesia
total norepinephrine dose
Time frame: 30 minutes after induction of anesthesia
Intra-operative inhalational anesthetic concentration
Time frame: 30 minutes
Incidence of post-induction hypotension
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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Sepsis
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.
Ahmed Mukhtar study director
Head of research committee section in anesthesia department
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 Ketamine, Fentanyl and Midazolam in people with Septic Shock, run by Cairo University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: 30 minutes after induction of anesthesia). 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 28 Jan 2020.