Acute Respiratory FailurePhase 2PROMINENCT05092152
Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients
A Phase 2 study testing Esketamine and Propofol in people with Acute Respiratory Failure, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Esketamine and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Oct 2021to 31 Dec 2023
- Phase
- Phase 2
- 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
- Age above 18 years old
- Physician indicated intubation
Who cannot join
- Pregnancy
- Intubation during cardiac arrest
- Known of suspected intracranial hypertension
- Know allergy to any of the study drugs (lidocaine, fentanyl, propofol, ketamine, or rocuronium)
- Bradycardia (heart rate below 50 beats per minute) or atrioventricular block without a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients: A Randomized, Multicenter, Unblinded, Clinical Trial
Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.
Read the detailed description
The optimal and safest hypnotic agent for rapid sequence intubation in critically ill patients remains uncertain. Factors such as hypovolemia, vasoplegia, hypoxemia, and acidosis can influence the efficacy and safety of induction agents. Propofol is commonly used for this purpose; however, it is associated with the risk of exacerbating hypotension. Ketamine, which has a more favorable hemodynamic profile, may offer a safer alternative in these patients. Objective: To assess whether ketamine is a safer alternative to propofol for rapid sequence intubation by reducing the incidence of hypotension during induction in critically ill patients.
Methods: This will be a randomized, open-label, pragmatic, bicenter study. A total of 170 critically ill patients requiring endotracheal intubation in the intensive care unit will be randomly assigned to receive either ketamine or propofol as the hypnotic agent. Randomization will be conducted using RedCap with a 1:1 ratio and variable block sizes, stratified by study site and vasopressor use during intubation. Results: The primary outcome will be the occurrence of hypotension, defined as the lowest mean arterial pressure recorded within the first 10 minutes following induction. Secondary outcomes, assessed within 1 hour post-induction, include mortality, incidence of cardiopulmonary arrest, the occurrence of severe hypotension (systolic blood pressure <80mmHg), the occurrence of severe hypoxemia (oxygen saturation < 85%), and the number of intubation attempts. Conclusion: The PROMINE study will provide valuable evidence to guide the selection of hypnotic agents for rapid sequence intubation in critically ill patients. It will contribute to a better understanding of the hemodynamic effects associated with propofol and ketamine in this context, potentially informing clinical practice.
- Conditions
- Acute Respiratory Failure
- Being tested
- Esketamine, Propofol
- Keywords
- rapid sequence intubation, intubation, airway management, propofol, ketamine, hypnotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
2 mg per kilogram of body weight
PropofolDrug
1.5 mg per kilogram of body weight
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Not described Receives: Drug: Propofol |
| Ketamine | Experimental | Not described Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest mean blood pressure
For the primary outcome, a pre-specified subgroup analysis will evaluate the following groups: patients < 70 versus ≥ 70 years old; patients with a Sequential Organ Failure Assessment (SOFA) score < 8 versus ≥ 8 points; patients on vasopressor versus without vasopressors; and patients with acute respiratory distress syndrome (ARDS) versus those without ARDS. Each subgroup analysis will be performed using linear regression, adjusted for baseline MAP before induction, total vasopressor dose in the first 10 minutes, age, and a random patient intercept. Effect estimates will be reported as mean differences with 95%CIs for each subgroup, with respective interaction p values. We will not adjust for multiplicity.
Measured: Ten minutes after induction
Secondary outcomes (6)
Average MAP within the first hour after induction
Average MAP within the first hour after induction
Measured: 1 hour
Early death
Death within one hour of intubation
Measured: 01 hour
Cardiac arrest
Cardiac arrest requiring resuscitation
Measured: 01 hour
Severe hypotension
Systolic blood pressure below 80 mmHg
Measured: 01 hour
Severe hypoxemia
Peripheral oxygen saturation below 85%
Measured: 01 hour
Time for successful intubation
Time for successful intubation
Measured: 01 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start23 Oct 2021
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Ribeiro Machado, Federal University of São Paulo
- Investigators
- Flavia R Machado, MD, PhD, Study chair, Federal University of São PauloRaysa Schmidt, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092152
- Sponsor's protocol ID
- PROMINE
- Acronym
- PROMINE
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be share after publication upon resonable request
Publications
Schmidt RC, Godinho Zampieri F, da Silva Ramos FJ, Santos Cavatoni Serra F, Maccagnan Pinheiro Besen BA, Fonseca Nunes N, Boschetti D, Chohfi Atallah F, Jackiu M, Garcia Melro LM, Nascimento Pontes CD, Vieira Tomotani DY, Petri Damiani L, Rezende de Freitas FG, Ribeiro Machado F; PROMINE Investigators. Propofol versus ketamine in rapid sequence intubation in critically ill patients: a prospective, randomized, controlled trial. Intensive Care Med. 2026 Mar;52(3):476-489. doi: 10.1007/s00134-026-08351-3. Epub 2026 Mar 23.
PubMed 41870554Schmidt RC, Zampieri FG, Ramos FJDS, Serra FSC, Damiani LP, Freitas FGR, Machado FR. Prospective, randomized, controlled trial comparing PROpofol versus KetaMINE in rapid sequence intubation in critically ill patients (PROMINE): protocol paper and statistical analysis plan. Crit Care Sci. 2025 Nov 17;37:e20250133. doi: 10.62675/2965-2774.20250133. eCollection 2025.
PubMed 41259542
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients: A Randomized, Multicenter, Unblinded, Clinical Trial
- ClinicalTrials.gov ID
- NCT05092152
- Acronym / sponsor ID
- PROMINE / PROMINE
- Conditions
- Acute Respiratory Failure
- Keywords
- rapid sequence intubation, intubation, airway management, propofol, ketamine, hypnotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 23 Oct 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Oct 2021 (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.
Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.
Detailed description
The optimal and safest hypnotic agent for rapid sequence intubation in critically ill patients remains uncertain. Factors such as hypovolemia, vasoplegia, hypoxemia, and acidosis can influence the efficacy and safety of induction agents. Propofol is commonly used for this purpose; however, it is associated with the risk of exacerbating hypotension. Ketamine, which has a more favorable hemodynamic profile, may offer a safer alternative in these patients. Objective: To assess whether ketamine is a safer alternative to propofol for rapid sequence intubation by reducing the incidence of hypotension during induction in critically ill patients.
Methods: This will be a randomized, open-label, pragmatic, bicenter study. A total of 170 critically ill patients requiring endotracheal intubation in the intensive care unit will be randomly assigned to receive either ketamine or propofol as the hypnotic agent. Randomization will be conducted using RedCap with a 1:1 ratio and variable block sizes, stratified by study site and vasopressor use during intubation. Results: The primary outcome will be the occurrence of hypotension, defined as the lowest mean arterial pressure recorded within the first 10 minutes following induction. Secondary outcomes, assessed within 1 hour post-induction, include mortality, incidence of cardiopulmonary arrest, the occurrence of severe hypotension (systolic blood pressure <80mmHg), the occurrence of severe hypoxemia (oxygen saturation < 85%), and the number of intubation attempts. Conclusion: The PROMINE study will provide valuable evidence to guide the selection of hypnotic agents for rapid sequence intubation in critically ill patients. It will contribute to a better understanding of the hemodynamic effects associated with propofol and ketamine in this context, potentially informing clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofol |
| Ketamine | Experimental | Drug: Esketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 18 years old
- Physician indicated intubation
Key exclusion criteria (5 listed)
- Pregnancy
- Intubation during cardiac arrest
- Known of suspected intracranial hypertension
- Know allergy to any of the study drugs (lidocaine, fentanyl, propofol, ketamine, or rocuronium)
- Bradycardia (heart rate below 50 beats per minute) or atrioventricular block without a pacemaker
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 |
|---|---|---|
| Esketamine2 mg per kilogram of body weight | Drug | Ketamine |
| Propofol1.5 mg per kilogram of body weight | Drug | Propofol |
Primary outcome
Lowest mean blood pressure
Time frame: Ten minutes after induction
For the primary outcome, a pre-specified subgroup analysis will evaluate the following groups: patients < 70 versus ≥ 70 years old; patients with a Sequential Organ Failure Assessment (SOFA) score < 8 versus ≥ 8 points; patients on vasopressor versus without vasopressors; and patients with acute respiratory distress syndrome (ARDS) versus those without ARDS. Each subgroup analysis will be performed using linear regression, adjusted for baseline MAP before induction, total vasopressor dose in the first 10 minutes, age, and a random patient intercept. Effect estimates will be reported as mean differences with 95%CIs for each subgroup, with respective interaction p values. We will not adjust for multiplicity.
6 secondary outcomes
Average MAP within the first hour after induction
Time frame: 1 hour
Early death
Time frame: 01 hour
Cardiac arrest
Time frame: 01 hour
Severe hypotension
Time frame: 01 hour
Severe hypoxemia
Time frame: 01 hour
Time for successful intubation
Time frame: 01 hour
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 17 Apr 2026.
- Derived from this study: PubMed 41870554Schmidt RC, Godinho Zampieri F, da Silva Ramos FJ, Santos Cavatoni Serra F, Maccagnan Pinheiro Besen BA, Fonseca Nunes N, Boschetti D, Chohfi Atallah F, Jackiu M, Garcia Melro LM, Nascimento Pontes CD, Vieira Tomotani DY, Petri Damiani L, Rezende de Freitas FG, Ribeiro Machado F; PROMINE Investigators. Propofol versus ketamine in rapid sequence intubation in critically ill patients: a prospective, randomized, controlled trial. Intensive Care Med. 2026 Mar;52(3):476-489. doi: 10.1007/s00134-026-08351-3. Epub 2026 Mar 23.
- Derived from this study: PubMed 41259542Schmidt RC, Zampieri FG, Ramos FJDS, Serra FSC, Damiani LP, Freitas FGR, Machado FR. Prospective, randomized, controlled trial comparing PROpofol versus KetaMINE in rapid sequence intubation in critically ill patients (PROMINE): protocol paper and statistical analysis plan. Crit Care Sci. 2025 Nov 17;37:e20250133. doi: 10.62675/2965-2774.20250133. eCollection 2025.
- Individual participant dataSharing planned: Yes. Data will be share after publication upon resonable request
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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.
Flavia R Machado, MD, PhD study chair
Federal University of São Paulo
Raysa Schmidt, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esketamine and Propofol in people with Acute Respiratory Failure, run by Federal University of São Paulo at 1 site in Brazil.
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 5 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 17 Apr 2026. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lowest mean blood pressure (time frame: Ten minutes after induction). 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 NCT05092152, which also lists 2 linked publications.
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 17 Apr 2026.