Short-, and long-term effects of the intra-operative nitrous oxide administration on the remifentanil-induced post-operative hyperalgesia, morphine consumption and long-term quality of life - nitrous oxide administration on the post-operative hyperalgesia
- Registration Number
- EUCTR2006-000875-14-BE
- Lead Sponsor
- AIR LIQUIDE SANTE INTERNATIONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 138
- types of surgery interventions: major abdominal surgeries with laparotomy of expected length of 4 hours or even specified
- adults: 18 to 65 years old
- ASA 1-3
- signed patient consent form
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
-Thoracic surgery
-Psychotropic agent chronic usage
-Chronic pain or chronic use of opioid analgesic
-Preceding major abdominal surgery
-Expected prolonged intubation
-Radiation in the area of surgery
-Regular intake of analgesics (except low dose acetylic acid for cardiovascular reasons)
-Opioid intake 24 hours before surgery
-Major obesity (BMI > 30)
-Drug or alcohol abuse
-Incapability of handling of PCA
-Instable or significant central nervous system, cardiac, hepatic, renal or endocrine dysfunction and/or significant sequelas
-Product-related exclusion criteria.
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