None listed
Conditions
Brief summary
Brief statement: Two types of general anaesthesia are given to patients to keep them asleep during the removal of clots causing large vessel strokes, most commonly either an anaesthetic gas (sevoflurane) delivered via inhalation, or medication (propofol) administered continuously through a drip. This study is a preliminary study looking to determine whether the choice of which of these methods used during the procedure makes a difference to how well a patient recovers. PROSPER will assess the feasibility of conducting a multi-site randomised control trial comparing two general anaesthetic techniques- volatile anaesthesia and total intravenous anaesthesia (TIVA) during endovascular thrombectomy for acute ischaemic stroke. PROSPER will primarily assess the hypothesis that the trial protocol is feasible. Secondary outcome measures will include functional recovery at 90 days primarily using modified Rankin scale (mRS). We will assess the data for potential relationships between mRS scores and intra and post-operative blood pressures, near infrared spectrometry (NIRS) calculated optimal blood pressure, pre- and post-operative risk factors and thrombolysis. PROSPER will be a pilot study prospective randomised controlled trial. Prospective data will be collected by the anaesthetic and stroke teams at the PA hospital. This data will include: • Baseline patient characteristics • Details of anaesthetic drugs administered • Physiological parameters measured during the clot retrieval procedure • Radiological outcome of procedure (TICI (thrombolysis in cerebral infarction) score) • Clinical outcome measures • Procedural complications, death rate and cause of death Data will be analysed in 2 groups – Volatile anaesthetic only after induction versus TIVA only after induction. Patients who change groups during the procedure (becoming a mixed group) will be treated with intention to treat analysis. We will report both feasibility for RCT and secondary outcomes.
Interventions
PROSPER will assess the feasibility of conducting a multi-site randomised control trial comparing two general anaesthetic techniques- volatile anaesthesia and total intravenous anaesthesia (TIVA) as maintenance of anaesthesia during endovascular thrombectomy for acute ischaemic stroke.
Prior to induction of anaesthesia, both treatment arms will be pre-oxygenated with 100% O2.
Anaesthetic protocols for the two treatment arms will then include:
1) Volatile group
Rapid sequence induction: intrav
PROSPER will assess the feasibility of conducting a multi-site randomised control trial comparing two general anaesthetic techniques- volatile anaesthesia and total intravenous anaesthesia (TIVA) as maintenance of anaesthesia during endovascular thrombectomy for acute ischaemic stroke. Prior to induction of anaesthesia, both treatment arms will be pre-oxygenated with 100% O2. Anaesthetic protocols for the two treatment arms will then include: 1) Volatile group Rapid sequence induction: intravenous delivery of propofol 1-3mg/kg, fentanyl 1-3mg/kg, suxamethonium 1-2mg/kg or rocuronium 1mg/kg or cisatracurium if contraindications to suxamethonium and rocuronium. Maintenance: Inhalational delivery of sevoflurane at a minimum alveolar concentration (MAC) of 0.5-1 (end-tidal anaesthetic gas concentrations [ET] of 1.6-2.4) with other opioids and muscle relaxants as required, at the discretion of the treating anaesthetist. 2) TIVA group Rapid sequence induction: intravenous infusion of propofol using propofol marsh model or Schneider model effect site concentration 1-5ng/ml, Remifentanil effect site concentration 1-5ng/ml, suxamethonium 1-2mg/kg or rocuronium 1mg/kg or cisatracurium if contraindications to suxamethonium and rocuronium. Maintenance: Propofol at a target-controlled infusion (TCI) dose of of 1-5, remifentanil at TCI 1-5, plus other opioids and muscle relaxants as required, at the discretion of the treating anaesthetist. In both groups the anaesthetist will aim for the following physiological targets, with techniques at their discretion: Oxygen saturation over 94% End tidal CO2 35-45 Systolic BP >140 prior to reperfusion, including during induction, and under 180 after reperfusion. Vasopressor usage will be documented and analysed in the final analysis. At the end of the case, the anaesthetist will ensure that the patient is fully reversed, pre-oxygenated, and extubated if possible. Patients will be managed post operatively to maintain systolic blood pressure less than 180mmHg. Patients will be recovered in the theatre recovery area if possible. Patients who are unable to be extubated, for reasons of pre-existing anaesthetic concerns, or intraoperative complications, will be admitted to ICU intubated, and anaesthesia maintained using propofol infusion at the discretion of the anaesthetist and ICU team.
Sponsors
Metro South Health via the Princess Alexandra Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult 18 years or over - Clot suitable for retrieval as determined by radiologist and neurologist - Physically independent prior to stroke, i.e., MRS less than or equal to 2 before stroke
Exclusion criteria
-Intubated prior to arrival at radiology suite -‘Rescue’ procedure for intraprocedural stroke, e.g., during carotid endarterectomy under general anaesthesia -Contraindication to particular anaesthetic agent, e.g. history of malignant hyperthermia, propofol allergy -ASA 5 -Anaesthetist refusal/ discomfort with alteration of individuals usual anaesthetic technique -Subsequent or prior enrolment in another clot retrieval drug study
Outcome results
None listed