drugset / Trial / NCT02229201

Comparison of Two Anaesthetics on Brain During Brain Tumour Surgery

NCT02229201

Phase 1 Completed 40 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-05
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 4 mg/kg Intravenous
Subject Propofol Small molecule 6 mg/kg Intravenous
Comparator Sevoflurane Other / unclassified 0.8 unknown Inhaled

Indications

No indication recorded.