Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients

NCT05092152 | Completed Phase 2 DMC

• 1 other identifier: PROMINE
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Failure

Keywords

rapid sequence intubation; intubation; airway management; propofol; ketamine; hypnotics

Outcome Measures

Primary Outcomes (1)

• 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.

  Ten minutes after induction

Secondary Outcomes (6)

• Average MAP within the first hour after induction

  1 hour

• Early death

  01 hour

• Cardiac arrest

  01 hour

• Severe hypotension

  01 hour

• Severe hypoxemia

  01 hour

Other Outcomes (13)

• The number of intubation attempts

  01 hour

• The highest heart rate (HR) within one hour after induction

  01 hour

• The total dose of vasopressors administered within the first 24 hours, using noradrenaline equivalent dose

  24 hours after intubation

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Drug: Propofol

Ketamine

EXPERIMENTAL

Drug: Esketamine

Interventions

Esketamine DRUG

2 mg per kilogram of body weight

Ketamine

Propofol DRUG

1.5 mg per kilogram of body weight

Propofol

Eligibility Criteria

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

You may qualify if:

• Age above 18 years old
• Physician indicated intubation

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04038002, Brazil

Location

Related Publications (2)

• 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 23. doi: 10.1007/s00134-026-08351-3. Online ahead of print.

  PMID: 41870554 DERIVED

• Schmidt 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.

  PMID: 41259542 DERIVED

MeSH Terms

Interventions

Esketamine; Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Flavia R Machado, MD, PhD

  Federal University of São Paulo

  STUDY CHAIR

• Raysa Schmidt, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Critical Care Department

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: October 23, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 17, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication
• Access Criteria: Upon reasonable request

Locations

BR (1)