Comparison of Two Anaesthetics on Brain During Brain Tumour Surgery
NCT02229201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2014-09-01
Summary
Anaesthesia and surgical stress during craniotomy can lead to brain damage and activation of inflammatory response. Consequently inflammatory cytokines (IL6, IL8, IL10) are released. Cell mediated immune balance can increase postoperative complications (infections, wound healing, multiple organ dysfunction). Many studies have shown that volatile anaesthetics reduce systemic and local inflammatory response during major surgery, but animal studies have shown that volatile anaesthetics can induce neuroinflammation (IL6, NF-κB) that leads to decline of cognitive function in rodent and possible human.
Our aim was to investigate how anaesthetic technique for craniotomy influences the release of inflammatory cytokines. Our hypothesis was that when optimal neuroprotective strategies are followed during surgery intravenous anaesthesia attenuates inflammatory response comparing to inhalational anaesthesia.
The investigators included 40 patients anaesthetised with remifentanil based anaesthesia with sevoflurane (S group) or propofol (P group).
Plasma levels of IL6, IL8, IL10 were measured during preoperative, perioperative and postoperative periods of both groups of patients. The investigators also noted emergence parameters, postoperative (pain, shivering, vomiting) and neurological complications after surgery.
Conditions
Interventions
- DRUG
-
Propofol
4-6 mg/kg/h during anaesthesia
- DRUG
-
Sevoflurane
0.8 MAC
Sponsors & Collaborators
-
University Medical Centre Ljubljana
lead OTHER
Principal Investigators
-
Jasmina Markovic Bozic, MD, MSC · CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan
-
Blaz Karpe, PHD · Faculty of Natural Science and Engineering, University of Ljubljana
-
Iztok Potocnik, MD, MSC · CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan
-
Ales Jerin, PHD · CLINICAL INSTITUTE OF CLINICAL CHEMISTRY AND BIOCHEMISTRY, University Medical Centre Ljubljana
-
Andrej Vranič, MD, PHD · CD of Neurosurgery, University Medical Centre Ljubljana
-
Vesna Novak Jankovic, PROF, PHD · CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- Slovenia
Study Locations
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