Skip to main content
OpenTrials
Completed

NCT Number: NCT05092152

Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of São Paulo

São Paulo, 04038002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years old
  • Physician indicated intubation

Exclusion criteria

  • 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

Treatment and study plan

Esketamine

Drug

2 mg per kilogram of body weight

Propofol

Drug

1.5 mg per kilogram of body weight

Primary outcomes

  1. 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.

Secondary outcomes

  1. Average MAP within the first hour after induction

    Time frame: 1 hour

    Average MAP within the first hour after induction

  2. Early death

    Time frame: 01 hour

    Death within one hour of intubation

  3. Cardiac arrest

    Time frame: 01 hour

    Cardiac arrest requiring resuscitation

  4. Severe hypotension

    Time frame: 01 hour

    Systolic blood pressure below 80 mmHg

  5. Severe hypoxemia

    Time frame: 01 hour

    Peripheral oxygen saturation below 85%

  6. Time for successful intubation

    Time frame: 01 hour

    Time for successful intubation

Other outcomes

  1. The number of intubation attempts

    Time frame: 01 hour

    The number of intubation attempts

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

    Time frame: 01 hour

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

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

    Time frame: 24 hours after intubation

    Cumulative, in milligrams, dose of vasopressors used

  4. Mean change in vasopressor dose (norepinephrine equivalent) from baseline to hour 1

    Time frame: 01 hour

    Mean change in vasopressor dose (norepinephrine equivalent) from baseline to hour 1

  5. Ventilator-free days within the first 7 days

    Time frame: 07 days

    Ventilator-free days within the first 7 days, defined as the number of days on which individuals are able to breathe spontaneously without any invasive ventilatory assistance, ascribing zero days to those who die, within 7 days.

  6. Mortality at day 7

    Time frame: Seven days

    Mortality at day 7

  7. ICU mortality

    Time frame: 60 days

    Mortality in the Intensive Care Unit

  8. Hospital mortality

    Time frame: 60 days

    Mortality in hospital

  9. Number of participants with Hypertension, defined as SBP > 180 mmHg

    Time frame: the first 10 minutes

    Number of participants with Hypertension, defined as SBP > 180 mmHg Safety outcomes during the first 10 minutes

  10. Number of participants with laryngospasm, as reported by the physician in charge of intubation

    Time frame: 10 minutes

    Laryngospasm, as reported by the physician in charge of intubation - safety outcome

  11. Number of participants with bradycardia, defined as HR < 45 bpm

    Time frame: 10 minutes

    Bradycardia, defined as HR < 45 bpm - safety outcome

  12. Number of participants with arrhythmias

    Time frame: 10 minutes

    Arrhythmias - safety outcome

  13. Number of participants with bronchoaspiration

    Time frame: 10 minutes

    Bronchoaspiration, defined as the presence of gastric content aspirated into the airway during intubation

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients: A Randomized, Multicenter, Unblinded, Clinical Trial

Acronym: PROMINE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.