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


- candidate number21867
- NTR NumberNTR5139
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2015
- Secondary IDsPARK-studie MEC-U
- Public TitleProcedural propofol sedation with ketamine versus alfentanil and remifentanil in patients for cardiac ablation.
- Scientific TitlePARK study
- ACRONYMPARK
- hypothesisIn this randomized, single blinded controlled trial, we evaluate the role of ketamine as an analgesic component of procedural sedation. We compare the effects of propofol-ketamine versus propofol-alfentanil and propofol-remifentanil for achieving a more acceptable respiratory stability during procedural sedation in patients scheduled for cardiac ablation treatment. 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.
- Healt Condition(s) or Problem(s) studiedPropofol, Ketamine , Alfentanil, Remifentanil , Sedation
- Inclusion criteriaPatients were eligible if scheduled for treatment of atrial fibrillation with cardiac ablation under procedural sedation, aged 18 years or older and with an 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, are receiving treatment for neuromuscular or psychiatric disease or have a physical or communicational disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate31-okt-2015
- Target number of participants235
- InterventionsFor analgesia during procedural sedation, randomly ketamine will be used. An induction dose of 0,1 mg/kg will be administered and ketamine will continuously be administered with a perfusor in a dose of 0,1 mg/kg/h. During the procedure, doses of ketamine will be fitted to the clinical situation, to reach and maintain an OAA/S score of at least 3, to consider hemodynamic stability and to achieve a pain score (NRS) of at least 4. Administration of ketamine will be raised or lowered when actual hemodynamic measurements differ at least 25% from baseline measurements, or if an OAA/S score unlike 3 or a pain score unlike 4 is achieved. Changes in ketamine dosing is showed in the following flowchart. Ketamine will be dosed in a range of 0,05 Ė 0,4 mg/kg/h. After finishing the procedure by the physician, administration of perfusor medication will be stopped and the recovery period starts, until an Aldrete score of at least 8 is achieved.
- Primary outcomeThe primary goal of this study is respiratory stability with the applied sedational technique. Differences of at least 10% in respiration rate, number of apneas and oxygen saturation with the applied inspiratory fraction of oxygen, in combination with the administered doses of procedural sedation medication, between three study groups will be compared and is regarded as a statistically significant difference.
- 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)
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)
Other study parameters:
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
− Time
T = 1 Start of induction of PSA
− Time
T = 2 End of induction (OAA/S ≤ 3)
− Hemodynamic parameters
− Respiratory parameters
− Sedation score
− Total doses of medications administered
− Time
T = 3 Start of the procedure
− Time
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
− Time
T = 6 End of PSA
− Hemodynamic parameters
− Respiratory parameters
− Sedation score
− Total doses of medications administered
− Aldrete score
− Pain score
− Time
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
− Time
T = 8 After discharge of the patient / procedure
− Patientís satisfaction
− Physicianís satisfaction
- Trial web siteX
- statusplanned
- CONTACT FOR PUBLIC QUERIES P.G.T.M. Broeren
- 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,
- PublicationsX
- Brief summaryX
- Main changes (audit trail)
- RECORD26-mrt-2015 - 1-mei-2015


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