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Comparison of Two Anaesthetics on Brain During Brain Tumour Surgery

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ClinicalTrials.gov Identifier: NCT02229201
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Jasmina Markovic Bozic, University Medical Centre Ljubljana

Brief 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.


Condition or disease Intervention/treatment Phase
Inflammation Drug: Propofol Drug: Sevoflurane Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Impact of Propofol vs. Sevoflurane on Brain Damage and Inflammatory Response During Brain Tumour Surgery
Study Start Date : May 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propofol
intravenous anaesthetic
Drug: Propofol
4-6 mg/kg/h during anaesthesia
Other Name: Propoven 1%

Active Comparator: Sevoflurane
volatile anaesthetic
Drug: Sevoflurane
0.8 MAC
Other Name: Sevorane




Primary Outcome Measures :
  1. Interleukin 10 plasma concentrations [ Time Frame: Within 48 hours (1. Before surgery and anaesthesia 2. During surgery, 3. At the end of surgery 4.First postoperative day 5.Second postoperative day) ]
    The interleukin 10 plasma concentrations during craniotomy (preoperative, perioperative and postoperative periods)


Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: within the first 15 days after surgery ]
  2. Pulmonary complications [ Time Frame: within the first 15 days after surgery ]
  3. Cardiovascular complications [ Time Frame: within the first 15 days after surgery ]
  4. Neurological complications [ Time Frame: within the first 15 days after surgery ]
  5. Reoperation [ Time Frame: within the first 15 days after surgery ]
  6. Death [ Time Frame: within the first 15 days after surgery ]
  7. Postoperative nausea and vomiting (PONV) [ Time Frame: within the first 24 hours after surgery ]
    Post anaesthetic adverse events and medication in ICU were recorded for a period of 24 h after anaesthesia. Adverse events were defined as any unintended changes in body function or well being.

  8. Pain using VAS score [ Time Frame: within the first 24 hours after surgery ]
    Post anaesthetic adverse events and medication in ICU were recorded for a period of 24 h after anaesthesia. Adverse events were defined as any unintended changes in body function or well being, in particular if clinical intervention or drug therapy was required.

  9. Change of blood pressure from the baseline [ Time Frame: within the first 24 hours after surgery ]
    Post anaesthetic adverse events and medication in ICU were recorded for a period of 24 h after anaesthesia. Adverse events were defined as any unintended changes in body function or well being, in particular if clinical intervention or drug therapy was required.


Other Outcome Measures:
  1. Consumption of Propofol (mg) [ Time Frame: within first 12 hours from the time before the surgery until the end of surgery ]
    Drugs consumption, volume loading, blood loss and post anaesthetic adverse events and medication were recorded:

  2. Consumption Remifentanil (mg) [ Time Frame: within first 12 hours from the time before the surgery until the end of surgery ]
    Drugs consumption, volume loading, blood loss and post anaesthetic adverse events and medication were recorded.

  3. Consumption of efedrin (mg) [ Time Frame: within first 12 hours from the time before the surgery until the end of surgery ]
    Efedrin was used for correction of low blood pressure

  4. Total loss of blood (ml) [ Time Frame: within first 12 hours from the time before the surgery until the end of surgery ]
  5. Time to extubation (min) [ Time Frame: within first 12 hours from the end of surgery until release from the recovery room ]
    Post anaesthetic adverse events and medication:

  6. Vomiting (yes/no) [ Time Frame: within first 12 hours from the end of surgery until release from the recovery room ]
    Post anaesthetic adverse events and medication:

  7. Lowering of arterial pressure (yes/no) [ Time Frame: within first 12 hours from the end of surgery until release from the recovery room ]
    Post anaesthetic adverse events and medication:

  8. Additional piritramid (yes/no) [ Time Frame: within first 12 hours from the end of surgery until release from the recovery room ]
    Post anaesthetic adverse events and medication:

  9. Consumption of fenilefrin (mikrog) [ Time Frame: within first 12 hours from the time before the surgery until the end of surgery ]
    Fenilefrin was used for low blood pressure correction

  10. Volume loading (ml) [ Time Frame: within first 12 hours from the time before the surgery until the end of surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-80 years
  • American Society of Anaesthesiologists (ASA) physical status I-III
  • Scheduled for brain tumour surgery
  • Glasgow Coma Score 15
  • Cooperative

Exclusion Criteria:

  • No written informed consent
  • Eendocrine systematic disease
  • Ddrugs that alter endocrine metabolism
  • History of drug hypersensitivity
  • Drug addiction
  • Perioperative blood derivatives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229201


Locations
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Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Jasmina Markovic Bozic, MD, MSC CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan
Principal Investigator: Blaz Karpe, PHD Faculty of Natural Science and Engineering, University of Ljubljana
Principal Investigator: Iztok Potocnik, MD, MSC CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan
Principal Investigator: Ales Jerin, PHD CLINICAL INSTITUTE OF CLINICAL CHEMISTRY AND BIOCHEMISTRY, University Medical Centre Ljubljana
Principal Investigator: Andrej Vranič, MD, PHD CD of Neurosurgery, University Medical Centre Ljubljana
Study Chair: Vesna Novak Jankovic, PROF, PHD CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jasmina Markovic Bozic, MD, MSC, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02229201     History of Changes
Other Study ID Numbers: UMCL-NKG-01
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by Jasmina Markovic Bozic, University Medical Centre Ljubljana:
propofol
sevoflurane
Interleukin 6
Interleukin 10
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Propofol
Anesthetics
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation