Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- incidence of postoperative headache (yes or no)
研究概览
简要总结
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, which is supposed to have protective effects on migraine patients, versus sevoflurane.
详细描述
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, versus sevoflurane. Propofol acts throught a GABA, and is known to have a therapeutic effect on migraine patients with accute attacts. However, its role on postoperative headache has not been studied, when used for maintainance of anaesthesia, this study aims to investigate the occurrence of headache after anaesthesia and surgery, when patients receive randomly two different anaesthetics: propofol and sevoflurane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient and the outcomes assessor will not know what kind of anaesthetic drug was used for maintainance of anaesthesia.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •scheduled operation under general anaesthesia
- •operations <4 hours
- •minorgynaecological operatios (leiomyomectomy)
- •hernia repair
- •arthroscopic procedurs
- •minor orthopaedic operations without the use of tourniquet or cement
- •saphenectomy
- •minor urologic operations
- •minor other operations of general surgery
排除标准
- •age <18 and >65 years old
- •Diseases of the central nervous system (ie Parkinsons's disease, Multiple sclerosis, previous ischaemic attack, hydrocephalus, seizure disorder, etc)
- •Psychosis under medication
- •Cognitive impairement or/and inability to fill in the questionaires
- •Allergy or contraindication to the study protocol included drugs
- •Operations of more than 4 hours duration
- •Head and neck procedures, procedures with neck extension (eg thyroidectomy), ENT procedures
- •renal impairement
- •hepatic impairement
- •patient refusal
研究组 & 干预措施
Sevoflurane
Sevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50).
干预措施: Sevoflurane (Drug)
Propofol
Total intravenous anaesthesia with propofol for maintainance of anaesthesia.Dose adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). Initial dose 10 mg/kg/h for10 min, 8 mg/kg/h for 10 min and then 6 mg/kg/h).
干预措施: Propofol (Drug)
结局指标
主要结局
incidence of postoperative headache (yes or no)
时间窗: up to 24 hours postoperatively
Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)
次要结局
- Nausea and vomiting(up to 24 hours postoperatively)
研究者
Chrysanthi Batistaki
Assistant Professor of Anaesthesiology
Attikon Hospital