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- Conditions
- elective ophthalmic surgery under general anesthesia.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-002883-20-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
-General anesthesia required for the procedure
-Age: 18 years and older
-American Society of Anesthesiologists (ASA) physical status I to III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
-Refusal to participate in this study
-Contra-indications for the use of propofol or remifentanil
-BMI > 35 kg/m2
-Central nervous system disorders (i.e. cerebrovascular accident, dementia, seizures, psychiatric disorders)
-Relevant hepatic disease (Child B or higher)
-Regular use of medication that affects the central nervous system (i.e. benzodiazepines, antidepressants, antipsychotics, antiepileptic drugs)
-Use of alpha-agonists or beta-blockers
-Overt signs of alcohol abuse
-Use of preoperative benzodiazepines (on the day of the study)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method