Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room

NCT06733129 | Recruiting Phase 3

• 1 other identifier: RC24_0389
• Study Type: interventional
• Target: 1,218
• Locations: 1 country
• Sites: 20

Brief 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. 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

Keywords

Rapid sequence induction; Full stomach patient; hypotension; propofol; ketamine; ketofol; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  within 10 minutes after the start of the hypnotic injection

Secondary Outcomes (15)

• rates of arterial hypotension episodes

  within 10 minutes after the start of the hypnotic injection

• rates of tracheal intubation at the first attempt

  within 10 minutes after the start of the hypnotic injection

• quality of the intubation

  within 10 minutes after the start of the hypnotic injection

• quality of the intubation

  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)

  within 10 minutes after the start of the hypnotic injection

Study Arms (3)

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

Drug: combination of Ketamine and Propofol

KETAMINE

EXPERIMENTAL

direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation

Drug: direct IV injection

PROPOFOL

ACTIVE COMPARATOR

direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation.

Drug: direct IV injection

Interventions

direct IV injection DRUG

direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation

KETAMINE; PROPOFOL

combination of Ketamine and Propofol DRUG

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.

KETOFOL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (20)

Chr Angers

Angers, France

RECRUITING

CHRU de Brest Hôpital Cavale Blanche

Brest, France

RECRUITING

Ch Louis Pasteur

Chartres, France

NOT YET RECRUITING

CHU Dijon

Dijon, France

RECRUITING

CHU Grenoble Alpes

Grenoble, France

NOT YET RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

APHP Bicêtre

Le Kremlin-Bicêtre, France

NOT YET RECRUITING

CH Le Mans

Le Mans, France

RECRUITING

CHU Lille Hopital Salengro

Lille, France

RECRUITING

CHU Lille Hôpital Claude Huriez

Lille, France

RECRUITING

CHU Lyon Hôpital Sud

Lyon, France

NOT YET RECRUITING

HCL Lyon Croix-Rousse

Lyon, France

NOT YET RECRUITING

Chu Nantes (Laennec)

Nantes, 44093, France

RECRUITING

Chu Nantes

Nantes, 44093, France

RECRUITING

APHP St-Antoine

Paris, France

NOT YET RECRUITING

APHP Tenon

Paris, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, France

RECRUITING

Hopital Foch

Suresnes, France

RECRUITING

CHU Toulouse Hôpital Purpan

Toulouse, France

NOT YET RECRUITING

CHU Toulouse Hôpital Rangueil

Toulouse, France

NOT YET RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s13063-026-09452-6. Online ahead of print.

  PMID: 41546091 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Propofol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Nicolas GRILLOT, MD

CONTACT

02 53 48 22 24; nicolas.grillot@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 13, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)