Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients

Acute Respiratory Failure Clinical Trial

— PROMINA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092152
• Other study ID #: PROMINA
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Federal University of São Paulo
• Contact: Raysa Schmidt, MD
• Phone: +551155764848
• Email: csraysa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years old
• Physician indicated intubation

Exclusion Criteria:

• Pregnancy
• Intubation during cardiac arrest
• Known of suspected intracranial hypertension
• Known allergy to propofol or esketamine
• Bradycardia (heart rate below 50 beats per minute) or atrioventricular block

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Esketamine hydrochloride
2 mg per kilogram of body weight
• Propofol
1.5 mg per kilogram of body weight

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative vasopressor use	Cumulative, in milligrams, dose of vasopressors used	24 hours after intubation
Other	Maximum heart rate	Maximum heart rate	One hour
Other	Days alive and free of mechanical ventilation	Days patient spend alive and free of mechanical ventilation in the first seven days after intubation	Seven days
Other	Mortality in the Intensive Care Unit	Mortality in the Intensive Care Unit	28 days
Other	Mortality in hospital	Mortality in hospital	28 days
Primary	Lowest mean blood pressure	Lowest mean blood pressure	Ten minutes after induction
Secondary	Early death	Death within one hour of intubation	One hour
Secondary	Cardiac arrest	Cardiac arrest requiring resuscitation	One hour
Secondary	Severe hypotension	Systolic blood pressure below 80 mmHg	One hour
Secondary	Severe hypoxemia	Peripheral oxygen saturation below 85%	One hour
Secondary	Number of intubation attempts	Number of attempts	One hour