A prospective single blinded (subject blinded) 1:1:1 randomised control trial with three parallel arms testing superiority of analgosedation regimen based on remimazolam and total intravenous anesthesia over propofol based analgosedation. The primary composite endpoint consists of hypoxaemia, hypotension, or hypertension requiring intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
127
analgosedation without secured airway
analgosedation with secured airway
TIVA with secured airway
University Hospital Kralovske Vinohrady
Prague, Czechia, Czechia
Primary composite endpoint (rate of hypoxaemia, hypotension, or hypertension events)
Composite endpoint consisting of the rate of (1) hypoxaemia events requiring intervention, (2) hypotension events requiring intervention or leading to the procedure interruption, or (3) hypertension events requiring intervention
Time frame: Procedure duration
Total number of haemodynamic instability events (hypoxemia, hypotension, hypertension; defined above), each five minutes of a continuous instability counts as a new event, as well as an instability persisting despite an intervention
Time frame: Procedure duration
Total number of: a) hypoxemia events hypoxaemia <85% (more than 60s) b) hypotension events = systolic blood pressure (SBP) < 85 mmHg (more than 60s) c) hypertension event = SBP > 200 mmHg (more than 60s)
Time frame: Procedure duration
Total number of interventions a) jaw thrust b) nasopharyngeal airway administration c) LMA / orotracheal intubation d) increasing FiO2 (oxygen flow) e) hypotensive drugs administration f) vasoactive drugs administration (ephedrine, noradrenaline)
Time frame: Procedure duration
Total procedural time
Time frame: Procedure duration
Analgosedation depth by bispectral (BIS) monitoring: area under the curve of BIS index (measured every 3 minutes during the procedure)
Time frame: Procedure duration
Procedural sedation quality
PROcedural Sedation Assessment Survey - a previously validated form
Time frame: 12-24 hours after the procedure
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Difficult sedation score
1-10 scale (10 = the worst), reported by an anaesthesiologist
Time frame: Procedure duration
Operator's satisfaction score
1-10 scale (10 = the worst), reported by the operating physician
Time frame: Procedure duration
Total number of serious adverse events
death, cardiopulmonary resuscitation (chest compression or adrenaline administration), an emergency intubation or prolonged stay in intensive care unit
Time frame: From randomization until discharge
carbon dioxide partial pressure after the procedure
partial pressure (kPa) of CO2 measured in an arterial blood sample
Time frame: blood sample taken after the procedure (up to 10 minutes)
28-day serious adverese events
death, a condition related to the procedure requiring inpatient hospitalization
Time frame: discharge to the day 28