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.
Conditions
Interventions
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 o
Sponsors
Catharina Hopsital Eindhoven
Eligibility
Inclusion criteria
Inclusion criteria: 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.
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, are receiving treatment for neuromuscular or psychiatric disease or have a physical or communicational disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
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) 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) 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) | — |
Contacts
Public ContactP.G.T.M. Broeren
Catharina Hospital Eindhoven
Outcome results
None listed