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Procedural propofol sedation with ketamine versus alfentanil and remifentanil in patients for cardiac ablation.


- candidate number21566
- NTR NumberNTR5032
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2015
- Secondary IDsFHJ van Loon
- Public TitleProcedural propofol sedation with ketamine versus alfentanil and remifentanil in patients for cardiac ablation.
- Scientific TitleProcedural propofol sedation with ketamine versus alfentanil and remifentanil in patients for cardiac ablation.
- ACRONYMPARK-study
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedAdverse events, Propofol, Ketamine , Alfentanil, Remifentanil
- 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 criteriaPatients 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2015
- planned closingdate31-dec-2015
- Target number of participants120
- InterventionsFor 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 Observerís 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 Ė 4 mg/kg/h and ketamine in a range of 0,05 Ė 0,4 mg/kg/h.
- Primary outcomeThe 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 outcomeSecondary outcome measures include:
Observerís 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
Patientís satisfaction (Likert five-item scoring system, 1 = not at all satisfied, 5 = extremely satisfied)
Physicianís 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)
- TimepointsT = 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 Ė 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
 Patientís satisfaction
 Physicianís satisfaction
- Trial web siteXXX
- statusplanned
- CONTACT FOR PUBLIC QUERIES Loes Braam
- CONTACT for SCIENTIFIC QUERIES F.H.J. Loon, van
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven,
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD13-jan-2015 - 12-apr-2015


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