We hypothesize that propofol combined with ketamine has an optimal respiratory stability with a significant decrease in respiratory side effects and complications, in comparison with propofol combined with either alfentanil or remifentanil.
ID
Bron
Verkorte titel
Aandoening
We designed this study to compare the effects of propofol-ketamine versus propofol-alfentanil and propofol-remifentanil for achieving a more acceptable respiratory stability with a decrease in respiratory side effects during PSA for CA treatment.
Ondersteuning
Michelangelolaan 2
5623 EJ Eindhoven
The Netherlands
040-2399111
www.cze.nl
Michelangelolaan 2
5623 EJ Eindhoven
The Netherlands
040-2399111
www.cze.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint of this study is respiratory stability with the applied sedational technique. Differences in respiration rate, number of apneas and oxygen saturation with the applied inspiratory fraction of oxygen, combined with the administered doses of PSA medication, between the three study groups will be compared.
Doel van het onderzoek
We hypothesize that propofol combined with ketamine has an optimal respiratory stability with a significant decrease in respiratory side effects and complications, in comparison with propofol combined with either alfentanil or remifentanil.
Onderzoeksopzet
T = 0 Before induction
Hemodynamic parameters
Demographic parameters
Medical and physical history
T = 1 Start of induction of PSA
T = 2 End of induction (OAA/S ≤ 3)
Hemodynamic parameters
Respiratory parameters
Sedation score
Total doses of medications administered
T = 3 Start of the procedure
T = 4 (4.1 – 4.9) Repeated every 15 minutes during the procedure
Hemodynamic parameters
Respiratory parameters
Sedation score
Total doses of medications administered
Time
T = 5 End of the procedure
T = 6 End of PSA
Hemodynamic parameters
Respiratory parameters
Sedation score
Total doses of medications administered
Aldrete score
Pain score
T = 7 During recovery (every 15 minutes) until Aldrete score > 8
Hemodynamic parameters
Respiratory parameters
Sedation score
Total doses of medications administered
Aldrete score
Pain score
T = 8 After discharge of the patient / procedure
Patient’s satisfaction
Physician’s satisfaction
Onderzoeksproduct en/of interventie
For sedation, a propofol perfusor will be started at 2 mg/kg/h, with an induction bolus of 0,5 mg/kg. Contemporaneously with propofol, ketamine will be administered via a perfusor at 0,3 mg/kg/h, with an induction bolus of 0,1 mg/kg. During the procedure, doses of propofol and ketamine will be fitted to the clinical situation, to reach and maintain an Observer’s Assessment of Alertness/ Sedation (OAA/S) score of at least 3, a pain score on a Numeric Rating Scale (NRS) of at least 4 and to consider hemodynamic stability. Propofol will be dosed in a range of 1 – 4 mg/kg/h and ketamine in a range of 0,05 – 0,4 mg/kg/h.
Publiek
Catharina Hospital Eindhoven <br>
Michelangelolaan 2 <br>
5623 EJ
Loes Braam
Eindhoven
The Netherlands
040-2399111 (sein 114521)
loes.braam@catharinaziekenhuis.nl
Wetenschappelijk
Catharina Hospital Eindhoven <br>
Michelangelolaan 2 <br>
5623 EJ
Loes Braam
Eindhoven
The Netherlands
040-2399111 (sein 114521)
loes.braam@catharinaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients were eligible if are: scheduled for treatment of atrial fibrillation with CA under PSA, aged 18 years or older, American Society of Anesthesiology (ASA) class 1 to 3.
Patients will be included in this study after given written informed consent before the treatment starts.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients will be excluded from the study if they: are unable to give informed consent, are pregnant, have a known allergy to either study medication, have a know contra-indication to administer either study medication, are scheduled for a repeated procedure, are receiving treatment for neuromuscular or psychiatric disease and have a physical or communicational disorder.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4930 |
NTR-old | NTR5032 |
Ander register | van Loon : FHJ |