In 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…
ID
Bron
Verkorte titel
Aandoening
We evaluate the role of administering ketamine as an analgesic component of anesthesia in procedural sedation and analgesia therapy (PSA), compared with other analgesics (opioids), because of the increasing importance of cardio-respiratory stability, patient’s and physician’s satisfaction and comfort during procedures with PSA.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The 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.
Achtergrond van het onderzoek
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Doel van het onderzoek
In 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.
Onderzoeksopzet
T = 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 – 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
− Patient’s satisfaction
− Physician’s satisfaction
Onderzoeksproduct en/of interventie
For 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 – 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.
Algemeen / deelnemers
P.G.T.M. Broeren
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
+31 40 239 9111
pim.broeren@catharinaziekenhuis.nl
Wetenschappers
P.G.T.M. Broeren
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
+31 40 239 9111
pim.broeren@catharinaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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, are receiving treatment for neuromuscular or psychiatric disease or have a physical or communicational disorder.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4892 |
| NTR-old | NTR5139 |
| Ander register | MEC-U : PARK-studie |