跳至主要内容
临床试验/NCT02708836
NCT02708836招募中不适用

Limiting Emergence Phenomena After General Anesthesia for Laparoscopic Surgery With Combined Laryngeal Mask Airway and Endotracheal Tube Airway Management Technique

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
2
主要终点
Change in rate pressure product during emergence

研究概览

简要总结

Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting emergence phenomena such as coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and tachycardia.

Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher ventilation pressures may be required, in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow the anesthesiologist to have little accessibility the airway.

The aim of this study is to investigate an airway management technique that would allow for the benefits of the ETT in terms of a secure airway for the duration of the surgical procedure as well the potential for less emergence phenomena seen when emerging with an LMA.

详细描述

Emergence from general anesthesia is a critical period of anesthetic management (1. Popat, 2012). The noxious stimuli of an endotracheal tube as well as the excitement stage of anesthesia, commonly seen prior to return of consciousness while emerging from general anesthesia, both lead to emergence phenomena of coughing, straining, and restlessness in addition to physiologic derangements (2. Atkinson, 1987). Physiologically, emergence from anesthesia is associated with rising sympathetic tone (as evidenced by elevated catecholamine levels and the resultant hemodynamic changes of increasing heart rate and blood pressure), intracranial pressure, and intraocular pressure. Airway tone and reflexes are also problematic as they may be depressed by the lingering pharmacologic effects of anesthetics and analgesics leading to decreased airway obstruction or aspiration events. Airway reflexes may also be exaggerated while traversing the excitement stage; this can lead to undesirable consequences of coughing, breath-holding, bucking or in extreme cases laryngospasm. A smooth emergence is preferable for all patients but is required for those patients who would not tolerate the above physiologic changes (e.g. severe aortic stenosis or coronary artery disease, both of which would poorly tolerate tachycardia) or those would be at risk in terms of the procedure that was performed (cerebral aneurysm clipping, carotid endarterectomy, thyroidectomy: procedures in which stress fresh surgical wounds with hypertension and straining would be undesirable).

Several airway management (3. Koga 1998, 4. Perello-Cerda 2015) and pharmacologic strategies (5. Minogue 20014, 6. Nho 2009, 7. Guler 2005) have been employed to provide a smooth emergence from general anesthesia. One of the most efficacious strategies is the use of supraglottic airway devices rather than endotracheal tubes. Despite evidence supporting the safety and efficacy of ventilation of SGAs during laparoscopic procedures (8. Natalini 2003, 9. Belena 2012, 10. Carron 2012, 11. Bernardini 2009), many anesthesiologists would prefer the use of an ETT to an SGA in cases in which higher ventilation pressures may be required (obesity, steep Trendeleberg position, pneumoperitoneum). In addition to the cases requiring high ventilation pressures, ETTs are preferred to SGAs in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents (non-fasted, intestinal obstruction, gastroparesis, parturients), as well as during cases that allow the anesthesiologist to have little accessibility the airway (neurosurgical, ENT, etc).

The Bailey maneuver (managing the airway with an ETT throughout the case and then exchanging for an LMA while deeply anesthetized (12. Nair 1995), has also been shown to provide less stimulating emergence. Unfortunately, the Bailey maneuver is relatively contraindicated in cases in which there is the perception that reintubation would be difficult, as the risks of exchanging a functioning airway device for one that has not been tested outweighs the potential benefits of a smooth emergence.

The airway management technique under investigation involves initially placing an LMA after induction of anesthesia. Once adequate ventilation has been accomplished using the LMA, the patient will be endotracheally intubated using a fiberoptic bronchoscope and the in situ LMA as a conduit (13. Timmermann 2011). General anesthesia will be maintained with sevoflurane and narcotics at the discretion of the primary anesthesiologist. The patient will be ventilated via the endotracheal tube during the duration of the surgical procedure and then the trachea will be extubated while the patient is at a deep plane of anesthesia after release of the pneumoperitoneum and return to supine positioning. This technique is a potential method for reducing the stress of emergence in patients who would benefit from the use of an endotracheal tube intraoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Participant)

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 undergoing elective laparoscopic surgery

排除标准

  • Individuals who cannot provide consent
  • Individuals who would require translation services to provide consent
  • Prisoners
  • Parturients
  • Non-fasted patients (as per HMC Anesthesiology Department NPO policy)
  • Patients felt to be high risk for gastric reflux and pulmonary aspiration (those with gastroparesis, symptomatic GERD, etc.: at the discretion of primary anesthesia team) Those patients with anticipated difficult airway requiring maintenance of spontaneous ventilation (awake intubation)

研究组 & 干预措施

ETT only

Active Comparator

Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.

干预措施: Induction of anesthesia (Procedure)

ETT only

Active Comparator

Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.

干预措施: Laryngoscopy and placement of ETT (Device)

ETT only

Active Comparator

Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.

干预措施: Ventilation via the ETT (Procedure)

ETT only

Active Comparator

Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.

干预措施: Removal of the ETT (Procedure)

ETT only

Active Comparator

Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.

干预措施: Emergence from anesthesia (Procedure)

Combined ETT/LMA technique

Experimental

Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

干预措施: Induction of anesthesia (Procedure)

Combined ETT/LMA technique

Experimental

Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

干预措施: Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask] (Device)

Combined ETT/LMA technique

Experimental

Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

干预措施: Ventilation via the ETT (Procedure)

Combined ETT/LMA technique

Experimental

Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

干预措施: Removal of the ETT (Procedure)

Combined ETT/LMA technique

Experimental

Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

干预措施: Intubation of the trachea through the LMA (Procedure)

Combined ETT/LMA technique

Experimental

Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

干预措施: Ventilation via the LMA (Procedure)

Combined ETT/LMA technique

Experimental

Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

干预措施: Emergence from anesthesia (Procedure)

结局指标

主要结局

Change in rate pressure product during emergence

时间窗: Intraoperative

Difference in heart rate multiplied by systolic blood pressure measured during the \~5 minutes prior to emergence and the \~5 minutes after removal of the airway device. Heart rate is continuously monitored and recorded at one minute intervals. Blood pressure is intermittently monitored at 3 minute intervals. The two SBPs measured prior to removal of the airway device will be multiplied by the HR at those times and the RPPs will be averaged. This will be compared with average of the product of the two SBPs and their corresponding HRs measured after removal of the airway device.

次要结局

  • Change in rate pressure product during induction of anesthesia and intubation(Intraoperative)
  • Presence/ severity of cough during prior to removal of airway device(Intraoperative)
  • Total opioids (morphine equivalents) administered intraoperatively(Intraoperative)
  • Time to successful ventilation via ETT(Intraoperative)
  • Success rate of ventilation with LMA after extubation of trachea(Intraoperative)
  • LMA cuff pressures when inflated to seal(Intraoperative)
  • Presence of sore throat.(Up to 1 week)
  • Presence/ severity of cough during after removal of airway device(Intraoperative)
  • LMA cuff pressures prior to removal of ETT.(Intraoperative)
  • Presence of oropharyngeal sensory or motor nerve palsy.(Up to 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taylor Anspach

Assistant Professor of Anesthesia and Perioperative Medicine

Milton S. Hershey Medical Center

研究点 (2)

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