Mild Hypothermia During Intracranial Aneurysm Clipping: Effect on Brain Microcirculation and Postoperative Vasospasms in Patients With Ruptured Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in Sidestream Dark Field (SDF) imaging variables
研究概览
简要总结
The purpose of this study is to determine whether mild hypothermia causes reduction of vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of vasospasms during the period of 14 postoperative days measured by transcranial Doppler.
详细描述
Methods: All the patients meeting the study criteria will be randomized into two groups. Normothermia (NT) group : during the whole period of surgery the body temperature will be maintained in the range 35.8° C - 36.8° C. Hypothermia (HT) group: After induction to general anaesthesia the patients will be cooled to body temperature 33.8° C - 34.8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping. Warming up of the patients will start immediately afterwards. The target temperature at the time of extubation will be over 36° C in both groups (one of the extubation criteria).
Specific management: No pharmacological sedation (premedication) will be given to the patients. Cooling/warming mattress/blanket (PlastiPad® Blanketrol® III Cincinnati Sub-Zero, USA) will be placed on the operating table. Induction to general anesthesia will be with propofol 2 mg/kg/b.w i.v. (with possible adjustment according to age and/or physical status of the patient) and atracurium 0,5 mg/kg/b.w. i.v. After orotracheal intubation, the esophageal temperature probe will be inserted (depth of insertion 25 cm from the nostril). Afterwards, the envelope with randomization will be opened by the anaesthesiologist.
In HT group, the targeted body temperature will be set to 33° C and a bolus of saline 250 ml cooled to 5° C will be administered.
In NT group, the targeted body temperature will be set to 36° C and a bolus of saline 250 ml warmed to 37° C using infusion heater will be administered.
Standard preparation for the surgery will continue afterwards (insertion of central venous catheter, arterial catheter, urinary catheter). After finishing the preparation (coming of the surgeon), the infusion of mannitol 15% at the dose 0,5 g/kg i.v. is started and set for the duration of 40 minutes. Monitoring: basic monitoring (SpO2, ECG, end-tidal carbon dioxide (EtCO2), NIBP) together with extended monitoring (invasive blood pressure, response entropy/state entropy (RE/SE), neuromuscular transmission module (NMT), surgical plethysmography index (SPI).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute subarachnoidal hemorrhage based on ruptured aneurysm
- •Hunt and Hess scale 1-4
- •Clipping up to 72 hours after the rupture
排除标准
- •Known cryoglobulinemia
研究组 & 干预措施
Mild hypothermia
After induction to general anaesthesia the patients will be cooled to 33° C. Targeted body temperature 33,8° C - 34,8° will be maintained up to the end of microcirculation measurement after aneurysm clipping.
干预措施: Mild hypothermia (Procedure)
Normothermia
The body temperature will be maintained in the range 35,8° C - 36,8° C.
结局指标
主要结局
Changes in Sidestream Dark Field (SDF) imaging variables
时间窗: 1 and 2 hours after skin incision
brain microcirculation will be measured by sidestream-dark field imaging (SDF) probe
次要结局
- Changes in diameter of small brain arteries at operating site(1 and 2 hours after skin incision)
- Occurrence of vasospasms(within the first 14 days after surgery)
研究者
Dostalova Vlasta, MD, PhD
Dostalova Vlasta, MD, PhD
University Hospital Hradec Kralove