NCT02708836 · Milton S. Hershey Medical Center
Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique
(LEPAGA)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Induction of anesthesia
At the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent
DEVICE
Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]
By standard method. Sizing at the discretion of the primary anesthesiologist.
DEVICE
Laryngoscopy and placement of ETT
Via direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien)
PROCEDURE
Ventilation via the ETT
Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
PROCEDURE
Removal of the ETT
Either upon emergence of anesthesia after suctioning of the oropharynx and after a positive pressure breath or while deeply anesthetized after release of the pneumoperitoneum in the combined LMA/ETT group.
PROCEDURE
Intubation of the trachea through the LMA
With ETT using fiberoptic bronchoscope guidance.
PROCEDURE
Ventilation via the LMA
After removal of the ETT. Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
PROCEDURE
Emergence from anesthesia
At the discretion of primary team. Airway device (either ETT or LMA) will be removed when patient is adequately ventilating and able to respond to commands (such as "open your eyes" or "squeeze my hand").
Primary outcome measures
Change in rate pressure product during emergence
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients undergoing elective laparoscopic surgery
Exclusion criteria
- Individuals who cannot provide consent
- Individuals who would require translation services to provide consent
- 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)
Where
- Hershey, Pennsylvania
Collaborators
Ambu A/S
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Data: ClinicalTrials.gov · synced Aug 14, 2025 · Source of record for eligibility and locations