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Procedural Propofol Sedation with ketamine versus alfentanil and remifentanil.


- candidate number18058
- NTR NumberNTR4633
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jun-2014
- Secondary IDs 
- Public TitleProcedural Propofol Sedation with ketamine versus alfentanil and remifentanil.
- Scientific TitleProcedural Propofol Sedation with ketamine versus alfentanil and remifentanil in patients for pulmonary vein isolation.
- ACRONYMKAUP-study
- hypothesisWe hypothesize that propofol combined with ketamine has a optimal physicianís satisfaction, patientís satisfaction and hemodynamic stability, in comparison with propofol combined with either alfentanil or remifentanil.
- Healt Condition(s) or Problem(s) studiedAnalgesia
- Inclusion criteriaInclusion criteria are requirement for PSA, patients aged 18 years or older and with an American Society of Anesthesiology 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 form the study if they are unable to give informed consent, are pregnant, has a known allergy to either study medication, are receiving treatment for neuromuscular or psychiatric disease or has a physical or communicational disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate31-dec-2014
- Target number of participants120
- InterventionsFor sedation, a propofol perfusor will be started combined with ketamine, even administered by perfusor. During the procedure, doses of propofol and ketamine will be fitted to the clinical situation, to reach and maintain an OAA/S score of at least 3 and to consider cardio-respiratory stability. After finishing the procedure by the physician, administration of perfusor medication will be ended.
- Primary outcomeThe primary endpoint of this study is physicianís satisfaction with the applied sedation technique, measured on a Likert five-item scoring system.
- Secondary outcomeObserverís Assessment of Alertness/ Sedation score, Ramsay score, hemodynamic parameters (mean heart rate, mean systolic blood pressure, mean diastolic blood pressure), respiratory parameters (mean Spo2 values, mean end-tidal co2 values, mean respiratory rated and number of apneas during the procedure), times (time of induction, time required for the procedure, sedation time and recovery time), total dosage of medication needed during the procedure, pain, Aldrete score, patientsí satisfaction and side effects (nausea, vomiting).
- TimepointsT = 0: before induction
T = 1: start of PSA
T = 2: end of induction PSA
T = 3: start of procedure by physician
T = 4: sedation parameters (every 15 minutes)
T = 5: end of procedure
T = 6: end of PSA
T = 7: start recovery
T = 8: end of recovery / discharge to the ward
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES F.H.J. Loon, van
- CONTACT for SCIENTIFIC QUERIES Loes Braam
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-jun-2014 - 4-jul-2014


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