Comparison of the quality of anesthesia and intraoperative stress responses to noxious stimulus with high opiate, low hypnotic versus low opiate high hypnotic drug administration during anesthesia using endocrinologic and immunologic markers and an off-line, post-hoc calculated surgical stress index during anesthesia with different steady-state concentrations of remifentanil and spectral entropy guided propofol administratio
- Conditions
- Comparing the intra-operative stress responses to noxious stimulus with high opiate, low hypnotic versus low opiate high hypnotic drug administration during anesthesia.Back surgeryMedDRA version: 8.1Level: LLTClassification code 10049130Term: Back surgery
- Registration Number
- EUCTR2006-003720-11-BE
- Lead Sponsor
- GE Healthcare Finland Oy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•ASA I and II
•male or female patients
•aged 18-65 years
•scheduled for surgery planned in the Operation Room schedule for more than 1 hour of duration.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Weight less than 70% or more than 130% of ideal body weight
•Neurological disorder
•Thyroid disorder
•Recent use of psycho-active medication, including alcohol.
•Patients taking any medication influencing heart rate variability (such as inotropic drugs, vagolytic drugs, beta-blockers, etc…).
•Patients having allergy to the study medication.
•Patients with a positive pregnancy test.
•Patients being included in another trial within 30 days prior to this study screening
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