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What is the difference in the safety of Ketamine versus Propofol when used to sedate Acute Psychiatric/ Psychotic Patients who require Aeromedical Retrieval?

The Safety of Ketamine versus Propofol in the Sedation of Acute Psychiatric/ Psychotic Patients requiring Aeromedical Retrieval - A Randomised Clinical trial

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001134415
Enrollment
119
Registered
2016-08-19
Start date
2016-09-16
Completion date
2020-09-02
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The inherent dangers of the aviation environment combined with the potential and unpredictable behaviour of acute psychiatric patients presents a challenge to even the most experienced aeromedical retrieval clinician. An efficacious sedation drug is vital in this environment to ensure crew and patient safety and to minimise patient distress. The incidence of psychiatric patients requiring retrieval from remote areas is increasing. Over a period of two years and nine months, CareFlight Northern Territory Operations has retrieved 660 psychiatric patients (01/02/2012 – 20/11/2014). There is no consensus on the optimal sedative to us in these patients. There has been no research undertaken that compares Ketamine and Propofol sedation in the aeromedical retrieval of acute psychiatric patients. Ketamine and Propofol are currently used within CareFlight Northern Territory Operations to sedate acute psychiatric patients who require aeromedical retrieval from their rural and remote areas. The primary purpose is to compare the safety and efficacy of sedating acute psychiatric patients with either Ketamine or Propofol whilst documenting and treating any potential complications that may arise. This study will also add to the paucity of literature on sedation methods for acute psychiatric patients requiring aeromedical retrieval. Study Hypothesis: Ketamine and Propofol are both as safe and efficacious as each other in sedating acute psychiatric patients who require aeromedical retrieval

Interventions

Sedation of acute psychiatric patients requiring aeromedical retrieval with Propofol versus Ketamine. Protocol for Administration Richmond Agitation Sedation Scale (RASS) will be utilised to measure sedation level. Propofol: The initial dose of Midazolam is determined by the RASS of the patient on arrival of the flight crew at the referral centre; a RASS of >+1, in the absence of premedication with a benzodiazepine,would indicate the need for an initial dose of Midazolam at 0.03mg/kg Propof

Sedation of acute psychiatric patients requiring aeromedical retrieval with Propofol versus Ketamine. Protocol for Administration Richmond Agitation Sedation Scale (RASS) will be utilised to measure sedation level. Propofol: The initial dose of Midazolam is determined by the RASS of the patient on arrival of the flight crew at the referral centre; a RASS of >+1, in the absence of premedication with a benzodiazepine,would indicate the need for an initial dose of Midazolam at 0.03mg/kg Propofol (Target RASS 0 to -3): (If the patient has not had any benzodiazepine): If Richmond agitation Sedation scale (RASS) >0 start with an initial dose of Midazolam 0.03mg/kg IV Prepare a Propofol syringe (200mg/20mls) Deliver ONE bolus of Propofol 0.25mg/kg to aim target RASS If further sedation required commence Propofol infusion to 0.25mg/kg/hr (approx. 3.5mls/hr) If RASS +1 increase Propofol infusion by 2mls every 5-10mins until target RASS of 0 to -3 is achieved If RASS +2 or higher, repeat IV Propofol bolus 0.25mg/kg to acutely reduce agitation If RASS -5 cease Propofol infusion until target RASS achieved, recommence infusion to maintain target RASS. For a SBP <90 administer a crystalloid bolus of 250mls Record the RASS, vital signs, and non-invasive end tidal carbon dioxide (ETCO2) levels every 10 minutes until arrival at receiving centre There is no maximum dose of Propofol to be administered as the timing of the retrieval cannot be strictly quantified. Please complete the data collection sheet before filing the patient notes The intervention period can last between 2-8 hrs. There a number of factors that impact on the duration of intervention; the time of preparing the patient at the referral centre, delay in road ambulance transport to the aircraft, the flight time and delays on road ambulance transport from Darwin International Airport to Royal Darwin Hospital. These factors can only be estimates of time as they vary widely, particularly the ambulance waiting periods from referral centres to the aircraft and from the aircraft to the Royal Darwin hospital.

Sponsors

CareFlight Limited
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All adult acute psychiatric patients requiring aeromedical retrieval

Exclusion criteria

Patients who known to be in their third trimester of pregnancy will be excluded

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026