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.
Conditions
Interventions
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
Sponsors
Catharina Hospital Eindhoven
Michelangelolaan 2
5623 EJ Eindhoven
The Netherlands
040-2399111
www.cze.nl
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactLoes Braam
Nurse anesthetist (PSA-specialist) Catharina Hospital Eindhoven Michelangelolaan 2 5623 EJ
Outcome results
None listed