Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients

Phase 2

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Drug: Propofol; Drug: Esketamine

• Registration Number: NCT05092152
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study Start: 2021-10-23
• Study First Posted: 2021-10-25
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	-
Ketamine	Esketamine	-

Primary Outcome Measures

Name	Time	Method
Lowest mean blood pressure	Ten minutes after induction	Lowest mean blood pressure

Secondary Outcome Measures

Name	Time	Method
Average MAP within the first hour after induction	1 hour	Average MAP within the first hour after induction
Early death	01 hour	Death within one hour of intubation
Cardiac arrest	01 hour	Cardiac arrest requiring resuscitation
Severe hypotension	01 hour	Systolic blood pressure below 80 mmHg
Severe hypoxemia	01 hour	Peripheral oxygen saturation below 85%
Time for successful intubation	01 hour	Time for successful intubation

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, São Paulo, Brazil