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ID
Source
Brief title
Health condition
We evaluate the role of injection of ketamine as an analgesic component of anesthesia in comparison with the other analgesics (opioids) in procedural sedation and analgesia therapy (PSA) because of the increasing importance of physician’s satisfaction during performing procedures and patient’s comfort.
Sponsors and support
Michelangelolaan 2
5623 EJ Eindhoven
The Netherlands
040-2399111
www.cze.nl
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is physician’s satisfaction with the applied sedation technique, measured on a Likert five-item scoring system.
Secondary outcome
Observer’s 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, patients’ satisfaction and side effects (nausea, vomiting).
Study objective
We hypothesize that propofol combined with ketamine has a optimal physician’s satisfaction, patient’s satisfaction and hemodynamic stability, in comparison with propofol combined with either alfentanil or remifentanil.
Study design
T = 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
Intervention
For 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.
Inclusion criteria
Inclusion 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 criteria
Patients 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL4515 |
| NTR-old | NTR4633 |
| Other | : |