Septic ShockPhase 3NCT03640468
Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients
A Phase 3 study testing Ketamine full dose, Ketamine half dose and Lidocaine in people with Septic Shock and Anesthesia, 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, Anesthesia
- What is being tested?
- Ketamine full dose, Ketamine half dose and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2018to 1 Jul 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 as an Adjuvant for Ketamine in 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, Anesthesia
- 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
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
MidazolamDrug
Also called Dormicum
This group will receive midazolam 0.05 mg/Kg
Normal salineDrug
This group will receive normal saline 10 mL
| 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: Ketamine half dose; Drug: Lidocaine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Mean arterial pressure measured in mmHg
Measured: 10 minutes after induction of general anesthesia
Secondary outcomes (4)
Heart rate
number of heart beats per minutes
Measured: 10 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
The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start20 Dec 2018 (estimated)
- Primary completion15 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Hasanin, Professor, Principal investigator, Assistant professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640468
- Sponsor's protocol ID
- N-128-2018
- Status last verified
- Nov 2018
- First submitted
- 18 Aug 2018
- Last updated
- 21 Nov 2018
- 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 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03640468
- Acronym / sponsor ID
- N-128-2018
- Conditions
- Septic Shock, Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2018 (estimated)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 21 Aug 2018 (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: Ketamine half dose, Drug: Lidocaine, Drug: MidazolamThis 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 |
| 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 | Drug | Lidocaine-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 |
Primary outcome
Mean arterial pressure
Time frame: 10 minutes after induction of general anesthesia
Mean arterial pressure measured in mmHg
4 secondary outcomes
Heart rate
Time frame: 10 minutes after induction of general anesthesia
Cardiac output
Time frame: 10 minutes after induction of general anesthesia
The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia
Time frame: 10 minutes after induction of general anesthesia
Norepinephrine consumption
Time frame: 10 minutes after induction of general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: No
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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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 Hasanin, Professor principal investigator
Assistant professor of anesthesia
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, Ketamine half dose and Lidocaine in people with Septic Shock and Anesthesia, 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: status not confirmed, as of the sponsor's last update on 21 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Amin, Lecturer (+201227476617, sarahamin_22@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial 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?
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 21 Nov 2018.