跳至主要内容
临床试验/NCT02988804
NCT02988804已完成不适用

Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery

Fundacion Clinic per a la Recerca Biomédica2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
systolic blood pressure

研究概览

简要总结

The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the incidence of complications is low, hypertensive episodes during surgery and awakening and cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or vomiting during the early postoperative period must be avoid to protect the patient from CSF leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a better haemodynamic profile and less incidence of cough in some surgical procedures and it could help minimizing the risks after EETS

详细描述

Randomization

At the end of surgery, the anesthesiologist will open a sealed envelope labeled with software-generated randomized numbers to assign the patients, who will be allocated in a 1:1 ratio from nonstratified blocks of four patients, to one of two groups to emerge from anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA (LMA group).

Study procedure

In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, the investigators will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique. Specifically, the LMA will be inserted after first advancing a suction catheter along the drain tube 8-10 cm beyond the distal end; the mask will be then inserted using a digital technique behind the orotracheal tube, allowing the suction catheter to enter the esophagus first and guiding the tip of the cuff. A number 4 or 5 mask will be chosen for patients weighing 50-70 kg or 70-100 kg, respectively. The cuff will be inflated to a pressure of 60 cmH2O measured with a manometer. Then the orotracheal tube balloon will be deflated and the tube removed. Ventilation then will be continued with the same parameters as had been used earlier.

Administration of neuromuscular relaxants will be then stopped so the patient could emerge from anesthesia. Once the patient recover 2/4 responses of the TOF, neostigmine (0.03 mg/Kg) and atropine (0.01mg/kg) will be given to reverse the neuromuscular blockade and Target-controlled infusion of anesthetics will be stopped. Lidocaine will not be administrated.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who undergo EETS in Hospital Clínic de Barcelona

排除标准

  • Re-interventions
  • Predicted difficult airway (severe acromegalia, mouth opening reduction) or Cormack-Lehane grade IV detected during laryngoscopy
  • Risk of bronchial aspiration (e.g., gastroesophageal reflux disease or lower cranial nerve palsy)
  • Uncontrolled arterial hypertension detected during preoperative assessment
  • Contraindication for early emergence based on anaesthetic or surgical criteria or as a result of complications developing during surgery

结局指标

主要结局

systolic blood pressure

时间窗: changes from baseline systolic blood pressure in the first 60 minutes after extubation

Changes in systolic blood pressure comparing two methods lma vs ett

次要结局

  • noradrenaline levels(changes from baseline noradrenaline level at 30 minutes after awakening)

研究者

发起方
Fundacion Clinic per a la Recerca Biomédica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricard Valero

MD, PhD

Fundacion Clinic per a la Recerca Biomédica

研究点 (2)

Loading locations...

相似试验