Induction of General AnesthesiaNCT05502211
A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease
A study testing Fentanyl and Lidocaine IV in people with Induction of General Anesthesia, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) presenting for coronary artery bypass grafting (CABG) represent a high-risk group among the cardiac surgical population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Induction of General Anesthesia
- What is being tested?
- Fentanyl and Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2022to 1 Dec 2022
- Phase
- Interventional
- 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
- Participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction < 40%), ASA physical status II-IV that will be scheduled for elective CABG surgery.
Who cannot join
- Patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (IABP), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study
Trial locations and contacts
2 sites in 1 country.
Monica Nashaat contact
Egypt2 sites, 2 recruiting
- Recruiting
Kasr Al Ainy
Cairo, 12566
Ramy Alkonaesy, MD, 01224883990
- Recruiting
Kasr al ainy
Cairo
Ramy Alkonaesy
About this study
Official title: A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction :( A Randomized Controlled Study
Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) presenting for coronary artery bypass grafting (CABG) represent a high-risk group among the cardiac surgical population. Anesthetic management of these patients is challenging due to increased risk of perioperative hypotension and subsequently increased risk of postoperative morbidity and mortality. Post induction hypotension is a modifiable risk that can be largely prevented by adjusting the technique for anesthesia induction. There is no consensus on the use of certain anesthetic induction techniques for patients CAD and left ventricular dysfunction. Anesthesia induction techniques for cardiovascular surgery are usually based on considerations such as hemodynamic stability, effects on myocardial oxygen supply, and demand and minimizing intubation stress response.To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with ketamine in patients with poor ventricular function.
- Conditions
- Induction of General Anesthesia
- Being tested
- Fentanyl, Lidocaine IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
induction of anaesthesia using fentanyl
Lidocaine IVDrug
induction of anesthesia using lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Not described Receives: Drug: Lidocaine IV |
| Fentanyl | Active comparator | Not described Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypotension
the number of patients who will develop hypotension
Measured: 15 minutes post inductin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of General AnesthesiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abougabal, Kasr El Aini Hospital
- Investigators
- Ayman Abougabal, MD, Study chair, lecturer of anesthesia Kasr Al Ainy hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502211
- Sponsor's protocol ID
- MS-230-2022
- Status last verified
- Oct 2022
- First submitted
- 12 Aug 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction :( A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05502211
- Acronym / sponsor ID
- MS-230-2022
- Conditions
- Induction of General Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Aug 2022 (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.
Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) presenting for coronary artery bypass grafting (CABG) represent a high-risk group among the cardiac surgical population. Anesthetic management of these patients is challenging due to increased risk of perioperative hypotension and subsequently increased risk of postoperative morbidity and mortality. Post induction hypotension is a modifiable risk that can be largely prevented by adjusting the technique for anesthesia induction. There is no consensus on the use of certain anesthetic induction techniques for patients CAD and left ventricular dysfunction. Anesthesia induction techniques for cardiovascular surgery are usually based on considerations such as hemodynamic stability, effects on myocardial oxygen supply, and demand and minimizing intubation stress response.To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with ketamine in patients with poor ventricular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine IV |
| Fentanyl | Active comparator | Drug: Fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction < 40%), ASA physical status II-IV that will be scheduled for elective CABG surgery.
Key exclusion criteria (1 listed)
- Patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (IABP), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study
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 |
|---|---|---|
| Fentanylinduction of anaesthesia using fentanyl | Drug | Fentanyl |
| Lidocaine IVinduction of anesthesia using lidocaine | Drug | Lidocaine |
Primary outcome
incidence of hypotension
Time frame: 15 minutes post inductin
the number of patients who will develop hypotension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Monica Nashaat contact
Ayman Abougabal, MD study chair
lecturer of anesthesia Kasr Al Ainy hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Lidocaine IV in people with Induction of General Anesthesia, run by Kasr El Aini Hospital at 2 sites 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 1 inclusion and 1 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 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Ayman Abougabal, MD (01020671408, ayman.abougabal@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypotension (time frame: 15 minutes post inductin). 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 20 Oct 2022.