Rapid Sequence InductionPhase 3HYPNOTIKSNCT06733129
Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room
A Phase 3 study testing direct IV injection and combination of Ketamine and Propofol in people with Rapid Sequence Induction, run by Nantes University Hospital at 20 sites in France.
Trial summary
The best hypnotic choice to optimize the balance between good intubation condition quality and hemodynamic stability during RSI performed in the operating theatre remained to be investigated. Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rapid Sequence Induction
- What is being tested?
- direct IV injection and combination of Ketamine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,218 participants
- Where
- 20 sitesFrance
- Study dates
- 14 Apr 2025to 30 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 - 80 years' old
- female* and male
- ≥ 1 risk factor of aspiration of gastric contents defined as
- preoperative fasting period of less than 6 hours,
- occlusive syndrome, functional ileus, vomiting episode within the last 12 hours,
- orthopaedic trauma within the last 12 hours,
Show all 10Show fewer
- medical history of symptomatic gastroesophageal reflux or hiatus, hernia or gastroparesis or dysautonomia or gastroesophageal surgery with sphincter dysfunction)
- patient requiring orotracheal intubation during general anaesthesia in the operating room.
- patient or his/her next of kin written informed consent or emergency procedure
- failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)
Who cannot join
- predicted impossible tracheal intubation (≥ 1 of the following criteria: patient with known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0 cm, Mouth Opening < 3 cm, Sternomental Distance < 12.5 cm, significant modification of the airway due to congenital, cancer, trauma or burning lesions (non-exhaustive list)) [30]
- preoperative arterial hypotension (MAP < 65 mmHg or under catecholamine)
- preoperative respiratory distress syndrome (SpO2 < 90% in room air)
- contraindications to the use of ketamine and/or propofol and/or NMB:
- allergy to the active substance or to one of the excipients or to soy or peanuts,
- porphyria
Show all 12Show fewer
- intracranial hypertension
- uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)
- personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase
- pregnancy or breast-feeding woman
- patients under court protection or guardianship
- absence of insurance covering health costs
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
Chr Angers
Angers
Sigismond LASOCKI, 02 41 35 36 35 ext. +33, silasocki@chu-angers.fr
Sigismond LASOCKI
- Recruiting
CHRU de Brest Hôpital Cavale Blanche
Brest
Anais CAILLARD, 02 98 34 76 23 ext. +33, anais.caillard@chu-brest.fr
Anais CAILLARD
- Not yet recruiting
Ch Louis Pasteur
Chartres
Nidhal CHEBBI
Nidhal CHEBBI
- Recruiting
CHU Dijon
Dijon
Pierre-Grégoire GUINOT, 03 80 28 15 54 ext. +33, guinotpierregregoire@gmail.com
Pierre-Grégoire GUINOT
- Not yet recruiting
CHU Grenoble Alpes
Grenoble
Pierre BOUZAT, 04 76 76 72 53 ext. +33, PBouzat@chu-grenoble.fr
Pierre BOUZAT
- Recruiting
CHD Vendée
La Roche-sur-Yon
Mathieu OUDOT, 02 51 44 62 37 ext. +33, Mathieu.oudot@chd-vendee.fr
Mathieu OUDOT
- Not yet recruiting
APHP Bicêtre
Le Kremlin-Bicêtre
Samy FIGUEIREDO, 01 45 21 34 41 ext. +33, samy.figueiredo@aphp.fr
Samy FIGUEIREDO
- Recruiting
CH Le Mans
Le Mans
Laurent BLANCHET, 02 43 43 28 40 ext. +33, lblanchet@ch-lemans.fr
Laurent BLANCHET
- Recruiting
CHU Lille Hopital Salengro
Lille
Nathalie BRUNEAU, 03 20 44 59 62 ext. +33, nathaliemarie.bruneau@chru-lille.fr
Nathalie BRUNEAU
- Recruiting
CHU Lille Hôpital Claude Huriez
Lille
Cédric CIRENEI, 03 20 44 59 62 ext. +33, cedric.cirenei@chu-lille.fr
cedric CIRENEI
- Not yet recruiting
CHU Lyon Hôpital Sud
Lyon
Jean-Stephane DAVID, 04 72 11 73 11 ext. +33, jean-stephane.david@univ-lyon1.fr
Jean-Stéphane DAVID
- Not yet recruiting
HCL Lyon Croix-Rousse
Lyon
Alice BLET, 04 72 07 12 39, alice.blet@chu-lyon.fr
Alice BLET
- Recruiting
Chu Nantes (Laennec)
Nantes, 44093
Xavier AMBROSI, 02 53 48 27 85 ext. +33, xavier.ambrosi@chu-nantes.fr
Xavier AMBROSI
- Recruiting
Chu Nantes
Nantes, 44093
Nicolas GRILLOT, MD, 02 53 48 22 24 ext. +33, nicolas.grillot@chu-nantes.fr
Antoine ROQUILLY
- Not yet recruiting
APHP St-Antoine
Paris
Franck VERDON, 01 71 97 70 70 ext. +33, franck.verdonk@aphp.fr
Franck VERDON
- Not yet recruiting
APHP Tenon
Paris
Franck VERDONK, 01 71 97 70 70 ext. +33, franck.verdonk@aphp.fr
Franck VERDONK
- Recruiting
CHU Poitiers
Poitiers
Quentin SAINT GENIS, 05 49 44 38 95 ext. +33, quentin.saint-genis@chu-poitiers.fr
Quentin SAINT-GENIS
- Recruiting
Hopital Foch
Suresnes
Morgan LE GUEN
Morgan LE GUEN
- Not yet recruiting
CHU Toulouse Hôpital Purpan
Toulouse
Maxime POMMIER, 05 61 77 23 88 ext. +33, pommier.max@chu-toulouse.fr
Maxime POMMIER
- Not yet recruiting
CHU Toulouse Hôpital Rangueil
Toulouse
Francois LABASTE, 05 61 32 28 22 ext. +33, labaste.f@chu-toulouse.fr
Francois LABASTE
About this study
Official title: Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial
The best hypnotic choice to optimize the balance between good intubation condition quality and hemodynamic stability during RSI performed in the operating theatre remained to be investigated.
Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate. So, we designed the HyPnotiKs randomized controlled study to investigate the efficacy of these hypnotic drugs in patients undergoing RSI in the operating theatre. The primary endpoint will be the successful tracheal intubation at the first attempt without major arterial hypotension event.
- Conditions
- Rapid Sequence Induction
- Being tested
- direct IV injection, combination of Ketamine and Propofol
- Keywords
- Rapid sequence induction, Full stomach patient, hypotension, propofol, ketamine, ketofol, general anesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct IV injectionDrug
direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI > 30) after completing pre-oxygenation
combination of Ketamine and PropofolDrug
combination of Ketamine and Propofol described above: consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg (adjusted body weight if BMI > 30). Dilution are not necessary.
| Study group | Role | What they receive |
|---|---|---|
| KETOFOL | Experimental | Ketofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation Receives: Drug: combination of Ketamine and Propofol |
| KETAMINE | Experimental | direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation Receives: Drug: direct IV injection |
| PROPOFOL | Active comparator | direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation. Receives: Drug: direct IV injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with successful intubation at first attempt and without post-induction hypotension
The main objective of the study is to compare the efficacies of ketamine alone and ketamine-propofol combination compared to standard doses of propofol to achieve successful tracheal intubation on the first attempt without hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room. The composite primary outcome is the proportion of patients with successful intubation at first attempt and without post-induction hypotension defined by a mean arterial pressure ≤ 60 mmHg within 10 minutes after the start of the hypnotic injection.
Measured: within 10 minutes after the start of the hypnotic injection
Secondary outcomes (15)
rates of arterial hypotension episodes
rates of arterial hypotension episodes as defined in primary endpoint within 10 minutes after induction of anaesthesia compared between the three study groups
Measured: within 10 minutes after the start of the hypnotic injection
rates of tracheal intubation at the first attempt
rates of tracheal intubation at the first attempt compared between the three study groups
Measured: within 10 minutes after the start of the hypnotic injection
quality of the intubation
In the operating theatre (within 10 minutes after the start of the hypnotic injection): intubation difficulty scale (IDS-3) values
Measured: within 10 minutes after the start of the hypnotic injection
quality of the intubation
In the operating theatre (within 10 minutes after the start of the hypnotic injection): Cormack-Lehane score values (from 1 to 4)
- Cormack 1: The glottis is seen in its entirety
- Cormack 2: Only the posterior half of the glottis is seen
- Cormack 3: Only a small part of the glottis is seen
- Cormack 4: The glottis is hidden by the epiglottis and tongue.
Measured: within 10 minutes after the start of the hypnotic injection
rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room)
In the operating theatre (within 10 minutes after the start of the hypnotic injection): rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room)
Measured: within 10 minutes after the start of the hypnotic injection
volume of intravenous fluids for vascular filling
volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room)
Measured: up to relapse of the recovery room (up to 7 days after surgery)
time between administration of hypnotic and tracheal intubation
Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : - time between administration of hypnotic (start of anesthetic induction) and tracheal intubation (defined as the 6th capnography curve)
Measured: within 10 minutes after the start of the hypnotic injection
values of heart rate
Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : values of heart rate measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection
Measured: within 10 minutes after the start of the hypnotic injection
values of SpO2
Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): SpO2 measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection
Measured: within 10 minutes after the start of the hypnotic injection
values of blood pressure
Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): systolic/diastolic/mean blood pressure measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection
Measured: within 10 minutes after the start of the hypnotic injection
rates of pulmonary aspiration of gastric contents
Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): rates of pulmonary aspiration of gastric contents during the intubation procedure
Measured: within 10 minutes after the start of the hypnotic injection
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room by postoperative Nu-DESC (Nursing Delirium Screening Scale) score value compared with preoperative score From 0 to 10
Measured: during stay in the recovery room
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room: need of sedative therapy in the recovery room to treat a delirium episode.
Measured: during stay in the recovery room
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room: Use of ketamine and total dose during intervention and total dose of ketamine in recovery room.
Measured: during stay in the recovery room (up to 7 days after induction)
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room:
Up to day 7:
- rates of major cardiovascular complications defined as: cardiac arrest, sustained arrhythmia, myocardial infarction, stroke (total, ischaemic, and haemorrhagic), coronary revascularization or admission to ICU for acute heart failure
- rates of mortality at day 7
Measured: within 7 days after the start of the hypnotic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start14 Apr 2025
- Primary completion14 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
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 Rapid Sequence InductionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733129
- Sponsor's protocol ID
- RC24_0389
- Acronym
- HYPNOTIKS
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grillot N, Volteau C, Quillet P, Ambrosi X, Caillard A, David JS, Blet A, Bouzat P, Blanchet L, Bruneau N, Chebbi N, Saint-Genis Q, Figueiredo S, Guinot PG, Joosten A, Le Guen M, Labaste F, Lasocki S, Oudot M, Pommier M, Rousseleau D, Verdonk F, Tching-Sin M, Faurel-Paul E, Counille F, Cosse C, Flattres Duchaussoy D, Cinotti R, Roquilly A. Best hypnotic drug choice for rapid sequence induction in the operating room: study protocol for a 3-arm superiority open-labeled randomized controlled trial with blinded evaluation of the primary outcome (the HyPnotiKs study). Trials. 2026 Jan 16;27(1):127. doi: 10.1186/s13063-026-09452-6.
PubMed 41546091
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial
- ClinicalTrials.gov ID
- NCT06733129
- Acronym / sponsor ID
- HYPNOTIKS / RC24_0389
- Conditions
- Rapid Sequence Induction
- Keywords
- Rapid sequence induction, Full stomach patient, hypotension, propofol, ketamine, ketofol, general anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,218 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 13 Dec 2024 (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 best hypnotic choice to optimize the balance between good intubation condition quality and hemodynamic stability during RSI performed in the operating theatre remained to be investigated.
Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate. So, we designed the HyPnotiKs randomized controlled study to investigate the efficacy of these hypnotic drugs in patients undergoing RSI in the operating theatre. The primary endpoint will be the successful tracheal intubation at the first attempt without major arterial hypotension event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KETOFOL | Experimental | Drug: combination of Ketamine and PropofolKetofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation |
| KETAMINE | Experimental | Drug: direct IV injectiondirect IV injection at dosage of 2 mg/kg after completing pre-oxygenation |
| PROPOFOL | Active comparator | Drug: direct IV injectiondirect IV injection at dosage of 2 mg/kg after completing pre-oxygenation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age between 18 - 80 years' old
- female* and male
- patient requiring orotracheal intubation during general anaesthesia in the operating room.
- patient or his/her next of kin written informed consent or emergency procedure
- failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)
Key exclusion criteria (12 listed)
- predicted impossible tracheal intubation (≥ 1 of the following criteria: patient with known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0 cm, Mouth Opening < 3 cm, Sternomental Distance < 12.5 cm, significant modification of the airway due to congenital, cancer, trauma or burning lesions (non-exhaustive list)) [30]
- preoperative arterial hypotension (MAP < 65 mmHg or under catecholamine)
- preoperative respiratory distress syndrome (SpO2 < 90% in room air)
- contraindications to the use of ketamine and/or propofol and/or NMB:
- pregnancy or breast-feeding woman
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 |
|---|---|---|
| direct IV injectiondirect IV injection at dosage of 2 mg/kg (adjusted body weight if BMI > 30) after completing pre-oxygenation | Drug | KETAMINE, PROPOFOL |
| combination of Ketamine and Propofolcombination of Ketamine and Propofol described above: consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg (adjusted body weight if BMI > 30). Dilution are not necessary. | Drug | KETOFOL |
Primary outcome
proportion of patients with successful intubation at first attempt and without post-induction hypotension
Time frame: within 10 minutes after the start of the hypnotic injection
The main objective of the study is to compare the efficacies of ketamine alone and ketamine-propofol combination compared to standard doses of propofol to achieve successful tracheal intubation on the first attempt without hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room. The composite primary outcome is the proportion of patients with successful intubation at first attempt and without post-induction hypotension defined by a mean arterial pressure ≤ 60 mmHg within 10 minutes after the start of the hypnotic injection.
15 secondary outcomes
rates of arterial hypotension episodes
Time frame: within 10 minutes after the start of the hypnotic injection
rates of tracheal intubation at the first attempt
Time frame: within 10 minutes after the start of the hypnotic injection
quality of the intubation
Time frame: within 10 minutes after the start of the hypnotic injection
quality of the intubation
Time frame: within 10 minutes after the start of the hypnotic injection
rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room)
Time frame: within 10 minutes after the start of the hypnotic injection
volume of intravenous fluids for vascular filling
Time frame: up to relapse of the recovery room (up to 7 days after surgery)
time between administration of hypnotic and tracheal intubation
Time frame: within 10 minutes after the start of the hypnotic injection
values of heart rate
Time frame: within 10 minutes after the start of the hypnotic injection
values of SpO2
Time frame: within 10 minutes after the start of the hypnotic injection
values of blood pressure
Time frame: within 10 minutes after the start of the hypnotic injection
rates of pulmonary aspiration of gastric contents
Time frame: within 10 minutes after the start of the hypnotic injection
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Time frame: during stay in the recovery room
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Time frame: during stay in the recovery room
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Time frame: during stay in the recovery room (up to 7 days after induction)
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
Time frame: within 7 days after the start of the hypnotic injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 41546091Grillot N, Volteau C, Quillet P, Ambrosi X, Caillard A, David JS, Blet A, Bouzat P, Blanchet L, Bruneau N, Chebbi N, Saint-Genis Q, Figueiredo S, Guinot PG, Joosten A, Le Guen M, Labaste F, Lasocki S, Oudot M, Pommier M, Rousseleau D, Verdonk F, Tching-Sin M, Faurel-Paul E, Counille F, Cosse C, Flattres Duchaussoy D, Cinotti R, Roquilly A. Best hypnotic drug choice for rapid sequence induction in the operating room: study protocol for a 3-arm superiority open-labeled randomized controlled trial with blinded evaluation of the primary outcome (the HyPnotiKs study). Trials. 2026 Jan 16;27(1):127. doi: 10.1186/s13063-026-09452-6.
- 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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing direct IV injection and combination of Ketamine and Propofol in people with Rapid Sequence Induction, run by Nantes University Hospital at 20 sites in France.
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 10 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GRILLOT, MD (02 53 48 22 24 ext. +33, nicolas.grillot@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with successful intubation at first attempt and without post-induction hypotension (time frame: within 10 minutes after the start of the hypnotic injection). 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 NCT06733129, 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 2 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.