Anesthesiological Strategies in Elective Craniotomy
关键词
抽象
描述
NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for a elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state evaluated with the ASA (I-III) and Glasgow Coma Scale (GCS) equal to 15, will be randomly assigned to one of three anesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanesthesia will be evaluated by comparing the intervals required to reach, after anesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil.
Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anesthesia; intraoperative adverse events (i.e. hypotension, hypertension, requirement of osmotic agents or/and hyperventilation for controlling brain swelling); evaluation of surgical field; postoperative adverse events (as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain); patient's satisfaction and an analysis of costs.
411 patients will be recruited in 14 different Italian centers during an 18-month period.
The recruitment started December 20th, 2007 and up to 11th March 2009.
日期
| 最后验证: | 08/31/2011 |
| 首次提交: | 08/21/2008 |
| 提交的预估入学人数: | 08/24/2008 |
| 首次发布: | 08/25/2008 |
| 上次提交的更新: | 09/06/2011 |
| 最近更新发布: | 09/07/2011 |
| 实际学习开始日期: | 11/30/2007 |
| 预计主要完成日期: | 02/28/2009 |
| 预计完成日期: | 11/30/2009 |
状况或疾病
干预/治疗
Drug: IF
Drug: IR
Drug: ER
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: IF Sevoflurane (Inhalation)+Fentanyl | Drug: IF Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and fentanyl (2-3 microg/kg/hr or 0.7 microg/kg boluses). Just before incision of the scalp, fentanyl (1-2microg/kg/hr) can be supplemented, if necessary |
| Experimental: IR Sevoflurane (Inhalation)+Remifentanyl | Drug: IR Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and remifentanil (0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening). Just before incision of the scalp, remifentanil can be supplemented, if necessary |
| Experimental: ER Propofol (Endovenous)+ Remifentanyl | Drug: ER Propofol is maintained with continuous infusion at 10 mg/kg/h for the first 10 minutes, then reduced to 8 mg/kg/h for the following 10 minutes and reduced to 6mg/kg/h thereafter and remifentanil 0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening. Just before incision of the scalp, remifentanil could be supplemented, if necessary |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion criteria: - Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours; - Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease); - Age 18-75 years; - Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15; - No signs of intracranial hypertension. Exclusion criteria: - Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve. - Renal or liver disease precluding the use of either anesthetic technique. - Pregnancy . - Known allergies to any anesthetic agent. - Reduced preoperative level of consciousness, i.e. - Glasgow Coma Scale (GCS) < 15. - Body weight greater than 120 kg. - History of drug abuse or psychiatric conditions. - Documented disturbance of the hypothalamic region.Refusal to sign consent form. - Participation in other clinical trials. - Delayed awakening, because, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned. |
结果
主要结果指标
1. Post-anesthesia awaking time, assessed as the interval (min:sec)required to reach an ALDRETE score ≥ 9 [From estubation to aldrete score ≥ 9]
次要成果指标
1. Neurovegetative stress [From induction of anesthesia to 24 hours after surgery]
2. Intraoperative and post-operative adverse events assessment [From induction of anesthesia to 24 hours after surgery]
3. Brain relaxation evaluated by a blinded neurosurgeon [From induction of anesthesia to 24 hours after surgery]
4. Patient's satisfaction [From induction of anesthesia to 24 hours after surgery]
5. Costs of the three strategies [From induction of anesthesia to end of surgery]
