Alfentanil versus fentanyl with ketamine for emergency department rapid sequence intubation: The A-FAKT study, a randomised clinical trial.

Phase 4

Recruiting

• Conditions: Rapid sequence intubation; Emergency medicine - Resuscitation

• Registration Number: ACTRN12621001764820
• Lead Sponsor: South West Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-23
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adult patients (18 years or older) undergoing rapid sequence intubation in participating emergency departments where the treating clinician intends to use an opioid in combination with ketamine and rocuronium.

Exclusion Criteria

•Allergy to study medications.
•Hypotensive at baseline (SBP <100 mmHg) or shock index (pulse/SBP >1.0)
•No doctor trained in the study protocol available to oversee.
•Alternative induction regime required in the judgment of the treating doctor.
•Overwhelmed emergency department in the judgment of the treating doctor.
•COVID or suspected COVID infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be a composite of:<br>•One or more episode of hypotension (systolic blood pressure <100mmHg within 6 minutes of induction, and/or;<br>•One or more episode of hypertension (systolic blood pressure >160mmHg within 6 minutes of induction, and/or;<br>•A rise in systolic blood pressure of >20% if the starting blood pressure exceeds 160mmHg.<br>A fall in systolic blood pressure of >20% if the starting blood pressure is below 100 mmHg.<br><br>Blood pressure will be measured using non-invasive oscillometry (an automated non-invasive blood pressure machine).<br>[Within six minutes of the induction of anaesthesia (defined as the commencement of the study drug bolus).]