Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients

Phase 2

Recruiting

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

• 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

Not available

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study Start: 2021-10-15
• Study First Posted: 2021-10-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamina	Esketamine hydrochloride	-
Propofol	Propofol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Severe hypotension	One hour	Systolic blood pressure below 80 mmHg
Severe hypoxemia	One hour	Peripheral oxygen saturation below 85%
Number of intubation attempts	One hour	Number of attempts
Cardiac arrest	One hour	Cardiac arrest requiring resuscitation
Early death	One hour	Death within one hour of intubation

Trial Locations

Locations (1)

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