Comparison of Two Anaesthetics on Brain During Brain Tumour Surgery

NCT02229201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-09-01

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229201 on ClinicalTrials.gov