None listed
Conditions
Brief summary
A small number of patients presenting to emergency departments need intubation, a process to place a tube in their windpipe to protect their airway, and allow breathing support with a ventilator. Drugs are used to ensure that they are unconscious and to relax their muscles to make placement of the tracheal tube possible, but these drugs can cause changes to vital signs such as pulse and blood pressure, which could worsen their condition. Ketamine is often used as a sedative agent for intubation, and an opioid (morphine-like) drug is sometimes used to try and normalise the blood pressure during the procedure. Fentanyl is the most commonly used opioid for this purpose, but another drug called alfentanil is theoretically a better choice. In this clinical trial, we intend to randomise patients to receive equivalent doses of either fentanyl or alfentanil, in a blinded fashion, as part of a drug regimen with ketamine and a muscle relaxant called rocuronium. The study aims to test the null hypothesis that there is no difference in the outcomes measured between fentanyl and alfentanil.
Interventions
Arm one will receive 2.5 - 15 micrograms per kilogram of alfentanil intravenously in addition to ketamine and rocuronium to facilitate rapid sequence intubation. The bolus of alfentanil will be given immediately prior to the other medications in the regimen (ketamine, followed by rocuronium) without a significant pause between.
The volume of intravenous alfentanil administered will be the equivalent that the treating doctor would administer if using open label fentanyl in a concentration of 10
Arm one will receive 2.5 - 15 micrograms per kilogram of alfentanil intravenously in addition to ketamine and rocuronium to facilitate rapid sequence intubation. The bolus of alfentanil will be given immediately prior to the other medications in the regimen (ketamine, followed by rocuronium) without a significant pause between. The volume of intravenous alfentanil administered will be the equivalent that the treating doctor would administer if using open label fentanyl in a concentration of 10 micrograms per millilitre. I.e. if the treating doctor would aim to administer 100 micrograms of open label fentanyl (10 ml in the concentration used in this study), they would administer 10 ml (containing 500 mcg) of alfentanil in this arm. The volume of medication administered will be recorded on the case report form, and also in a separate controlled drugs register, which will be checked by two independent staff members.
Sponsors
South West Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed