Procedural Propofol Sedation with ketamine versus alfentanil and remifentanil.
- Conditions
- 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.
- Registration Number
- NL-OMON29416
- Lead Sponsor
- Catharina Hospital EindhovenMichelangelolaan 25623 EJ EindhovenThe Netherlands040-2399111www.cze.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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).<br>