Inflammation Clinical Trial
Official title:
Phase 1 Study of the Impact of Propofol vs. Sevoflurane on Brain Damage and Inflammatory Response During Brain Tumour Surgery
Verified date | August 2014 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Slovenia | University Medical Centre Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Blum FE, Zuo Z. Volatile anesthetics-induced neuroinflammatory and anti-inflammatory responses. Med Gas Res. 2013 Aug 1;3(1):16. doi: 10.1186/2045-9912-3-16. — View Citation
El Beheiry H. Protecting the brain during neurosurgical procedures: strategies that can work. Curr Opin Anaesthesiol. 2012 Oct;25(5):548-55. doi: 10.1097/ACO.0b013e3283579622. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Consumption of Propofol (mg) | Drugs consumption, volume loading, blood loss and post anaesthetic adverse events and medication were recorded: | within first 12 hours from the time before the surgery until the end of surgery | Yes |
Other | Consumption Remifentanil (mg) | Drugs consumption, volume loading, blood loss and post anaesthetic adverse events and medication were recorded. | within first 12 hours from the time before the surgery until the end of surgery | Yes |
Other | Consumption of efedrin (mg) | Efedrin was used for correction of low blood pressure | within first 12 hours from the time before the surgery until the end of surgery | Yes |
Other | Total loss of blood (ml) | within first 12 hours from the time before the surgery until the end of surgery | Yes | |
Other | Time to extubation (min) | Post anaesthetic adverse events and medication: | within first 12 hours from the end of surgery until release from the recovery room | Yes |
Other | Vomiting (yes/no) | Post anaesthetic adverse events and medication: | within first 12 hours from the end of surgery until release from the recovery room | Yes |
Other | Lowering of arterial pressure (yes/no) | Post anaesthetic adverse events and medication: | within first 12 hours from the end of surgery until release from the recovery room | Yes |
Other | Additional piritramid (yes/no) | Post anaesthetic adverse events and medication: | within first 12 hours from the end of surgery until release from the recovery room | Yes |
Other | Consumption of fenilefrin (mikrog) | Fenilefrin was used for low blood pressure correction | within first 12 hours from the time before the surgery until the end of surgery | Yes |
Other | Volume loading (ml) | within first 12 hours from the time before the surgery until the end of surgery | Yes | |
Primary | Interleukin 10 plasma concentrations | The interleukin 10 plasma concentrations during craniotomy (preoperative, perioperative and postoperative periods) | 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) | Yes |
Secondary | Hospital stay | within the first 15 days after surgery | Yes | |
Secondary | Pulmonary complications | within the first 15 days after surgery | Yes | |
Secondary | Cardiovascular complications | within the first 15 days after surgery | Yes | |
Secondary | Neurological complications | within the first 15 days after surgery | Yes | |
Secondary | Reoperation | within the first 15 days after surgery | Yes | |
Secondary | Death | within the first 15 days after surgery | Yes | |
Secondary | Postoperative nausea and vomiting (PONV) | 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. | within the first 24 hours after surgery | Yes |
Secondary | Pain using VAS score | 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. | within the first 24 hours after surgery | Yes |
Secondary | Change of blood pressure from the baseline | 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. | within the first 24 hours after surgery | Yes |
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