Septic ShockPhase 3NCT03844984
Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients
A Phase 3 study testing ketamine full dose, Midazolam and Normal saline in people with Septic Shock, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- ketamine full dose, Midazolam and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2019to 20 Sep 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged above 18 years
- With septic shock
- Scheduled for general anesthesia
Who cannot join
- Patients under 18 years
- Burn patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.
Read the detailed description
Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.
Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.
Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.
- 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.
ketamine full doseDrug
Also called Ketamine hydrochloride
This group will receive induction of anesthesia using Ketamine 1 mg/Kg.
MidazolamDrug
Also called dormicum
This group will receive midazolam 0.05 mg/Kg
Normal salineDrug
This group will receive normal saline 10 mL
ketamine half doseDrug
Also called Ketamine hydrochloride
This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.
LidocaineDrug
Also called Lidocaine hydrochloride
This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Active comparator | This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL. Receives: Drug: ketamine full dose; Drug: Midazolam; Drug: Normal saline |
| Lidocaine-ketamine group | Experimental | This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg. Receives: Drug: Midazolam; Drug: ketamine half dose; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure
Mean arterial blood pressure measured in mmHg
Measured: 10 minutes after induction of general anesthesia
Secondary outcomes (5)
Heart rate
Number of heart beats per minute
Measured: 10 minutes after induction of general anesthesia
The number of patients who suffer from post-induction hypotension.
The number of patients who suffer from decreased mean arterial pressure by 10% from the baseline reading during the first 5 minutes after induction of anesthesia
Measured: 5 minutes after induction of general anesthesia
Cardiac output
Volume of blood pumped by the heart in one minute measured in liters per minute
Measured: 10 minutes after induction of general anesthesia
Norepinephrine consumption
The total dose of norepinephrine measured in micrograms
Measured: 10 minutes after induction of general anesthesia
Systolic blood pressure
Systolic arterial blood pressure measured in mmHg
Measured: 10 minutes after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start20 Feb 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ashraf Rady, Professor, Study chair, Head of department of anesthesia, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844984
- Sponsor's protocol ID
- N128-2018
- Status last verified
- Nov 2019
- First submitted
- 15 Feb 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fathy S, Hasanin A, Mostafa M, Ramzy E, Sarhan K, Almenesey T, Safina AG, Hosny O, Hamden GA, Gado AA, Mokhtar A. The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100731. doi: 10.1016/j.accpm.2020.06.017. Epub 2020 Sep 5.
PubMed 32898698
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03844984
- Acronym / sponsor ID
- N128-2018
- Conditions
- Septic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 19 Feb 2019 (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 the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.
Detailed description
Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.
Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.
Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.
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 | Active comparator | Drug: ketamine full dose, Drug: Midazolam, Drug: Normal salineThis group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL. |
| Lidocaine-ketamine group | Experimental | Drug: Midazolam, Drug: ketamine half dose, Drug: LidocaineThis group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged above 18 years
- With septic shock
- Scheduled for general anesthesia
Key exclusion criteria (2 listed)
- Patients under 18 years
- Burn patients
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 |
|---|---|---|
| ketamine full doseAlso: Ketamine hydrochlorideThis group will receive induction of anesthesia using Ketamine 1 mg/Kg. | Drug | Ketamine group |
| MidazolamAlso: dormicumThis group will receive midazolam 0.05 mg/Kg | Drug | Ketamine group, Lidocaine-ketamine group |
| Normal salineThis group will receive normal saline 10 mL | Drug | Ketamine group |
| ketamine half doseAlso: Ketamine hydrochlorideThis group will receive induction of anesthesia using Ketamine 0.5 mg/Kg. | Drug | Lidocaine-ketamine group |
| LidocaineAlso: Lidocaine hydrochlorideThis group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline. | Drug | Lidocaine-ketamine group |
Primary outcome
Mean arterial blood pressure
Time frame: 10 minutes after induction of general anesthesia
Mean arterial blood pressure measured in mmHg
5 secondary outcomes
Heart rate
Time frame: 10 minutes after induction of general anesthesia
The number of patients who suffer from post-induction hypotension.
Time frame: 5 minutes after induction of general anesthesia
Cardiac output
Time frame: 10 minutes after induction of general anesthesia
Norepinephrine consumption
Time frame: 10 minutes after induction of general anesthesia
Systolic blood pressure
Time frame: 10 minutes after induction of general anesthesia
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 26 Nov 2019.
- Derived from this study: PubMed 32898698Fathy S, Hasanin A, Mostafa M, Ramzy E, Sarhan K, Almenesey T, Safina AG, Hosny O, Hamden GA, Gado AA, Mokhtar A. The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100731. doi: 10.1016/j.accpm.2020.06.017. Epub 2020 Sep 5.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
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.
Ashraf Rady, Professor study chair
Head of department of anesthesia, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketamine full dose, Midazolam and Normal saline 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 3 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 26 Nov 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 blood pressure (time frame: 10 minutes after induction of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844984, which also lists 1 linked publication.
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 26 Nov 2019.