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ID
Source
Brief title
Health condition
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.
Sponsors and support
Michelangelolaan 2
5623 EJ Eindhoven
The Netherlands
040-2399111
www.cze.nl
Michelangelolaan 2
5623 EJ Eindhoven
The Netherlands
040-2399111
www.cze.nl
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary outcome measures include:
Observer’s Assessment of Alertness/ Sedation score; OAA/S (0 = fully sedated, 5 = not sedated)
Ramsay score; RS (1 = anxious or restless or both, 8 = no response, even to pain)
Hemodynamic parameters (mean heart rate, mean systolic blood pressure and mean diastolic blood pressure)v
Times (time required for the induction of PSA, time required for the procedure, total time PSA is administered and total recovery time)
Total dosages of medication administered during the procedure
Numeric Rating Scale; NRS (0 = no pain, 10 = worst imaginable pain)
Aldrete score
Patient’s satisfaction (Likert five-item scoring system, 1 = not at all satisfied, 5 = extremely satisfied)
Physician’s satisfaction (Likert five-item scoring system, 1 = not at all satisfied, 5 = extremely satisfied)
Side effects (nausea, vomiting)
Demographic characteristics (sex, age, length, weight, BMI, ASA physical status)
Medical history (cardiac status, pulmonary status, renal status, diabetes mellitus, other diseases)
Physical history (smoking, alcohol abuses, drugs abuses, history of PONV)
Study objective
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.
Study design
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
Intervention
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.
Catharina Hospital Eindhoven <br>
Michelangelolaan 2 <br>
5623 EJ
Loes Braam
Eindhoven
The Netherlands
040-2399111 (sein 114521)
loes.braam@catharinaziekenhuis.nl
Catharina Hospital Eindhoven <br>
Michelangelolaan 2 <br>
5623 EJ
Loes Braam
Eindhoven
The Netherlands
040-2399111 (sein 114521)
loes.braam@catharinaziekenhuis.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL4930 |
NTR-old | NTR5032 |
Other | van Loon : FHJ |