Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients

NCT ID: NCT05092152

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-23
• Study Completion Date: 2023-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Propofol

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

1.5 mg per kilogram of body weight

Ketamine

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

2 mg per kilogram of body weight

Interventions

Esketamine

2 mg per kilogram of body weight

Intervention Type: DRUG

Propofol

1.5 mg per kilogram of body weight

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Flavia Ribeiro Machado

Chair of Critical Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavia R Machado, MD, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Raysa Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PROMINE

Identifier Type: -

Identifier Source: org_study_id