Phase 1 Study of the Impact of Propofol vs. Sevoflurane on Brain Damage and Inflammatory Response During Brain Tumour Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Interleukin 10 plasma concentrations
研究概览
简要总结
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.
详细描述
Anaesthetic technique for craniotomy has to provide optimal cerebral perfusion, oxygenation and prevent brain oedema (1). It also has to lower the stress response on pain during intubation and surgical manipulation. Emergence from anaesthesia has to be rapid and smooth to permit early postoperative neurological evaluation. The most likely opioid in the last decade is short acting opioid remifentanil that can be easy titrated during the procedure and provides early recovery (2, 3, 4, 5). Currently the propofol-remifentanil and sevoflurane-remifentanil are the most frequently used combinations for craniotomy (6, 7). Recently a multicentre study was published that did not show differences in early recovery between three groups (propofol-remifentanil: TIVA, sevoflurane-remifentanil, sevoflurane-fentanyl). Either technique provided optimal surgical conditions. The group received TIVA had attenuated changes in stress biomarkers (cortizol in plasma and urine, cateholamines. (8).
Anaesthesia and surgical stress during craniotomy can lead to brain damage and activation of inflammatory response (9, 10). 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 (11, 12, 13, 14), 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 (15,16).
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.
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.
Patients and methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •American Society of Anaesthesiologists (ASA) physical status I-III
- •Scheduled for brain tumour surgery
- •Glasgow Coma Score 15
- •Cooperative
排除标准
- •No written informed consent
- •Eendocrine systematic disease
- •Ddrugs that alter endocrine metabolism
- •History of drug hypersensitivity
- •Drug addiction
- •Perioperative blood derivatives.
研究组 & 干预措施
Propofol
intravenous anaesthetic
干预措施: Propofol (Drug)
Sevoflurane
volatile anaesthetic
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Interleukin 10 plasma concentrations
时间窗: 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)
次要结局
- Hospital stay(within the first 15 days after surgery)
- Pulmonary complications(within the first 15 days after surgery)
- Cardiovascular complications(within the first 15 days after surgery)
- Neurological complications(within the first 15 days after surgery)
- Reoperation(within the first 15 days after surgery)
- Death(within the first 15 days after surgery)
- Postoperative nausea and vomiting (PONV)(within the first 24 hours after surgery)
- Pain using VAS score(within the first 24 hours after surgery)
- Change of blood pressure from the baseline(within the first 24 hours after surgery)
研究者
Jasmina Markovic Bozic
MD, MSC
University Medical Centre Ljubljana