Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique

Official title

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

Overview

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.

Detailed description

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.

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]

Secondary outcome measures (10)

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

Eligibility criteria

Inclusion criteria

• ASA 1-3
• Patients undergoing elective laparoscopic surgery

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Single blind

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Penn State Health - Hershey Medical Center — Hershey

Publications

• Difficult Airway Society Extubation Guidelines Group; Popat M, Mitchell V, Dravid R, Patel A, Swampillai C, Higgs A. Difficult Airway Society Guidelines for the management of tracheal extubation. Anaesthesia. 2012 Mar;67(3):318-40. doi: 10.1111/j.1365-2044.2012.07075.x. PMID 22321104
• Atkinson RS, Rushman GB, Alfred Lee J: A Synopsis of Anaesthesia, 10th edition. Butterworth-Heinemann Ltd, 1987, pp 165-9
• Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x. PMID 9709138
• Perello-Cerda L, Fabregas N, Lopez AM, Rios J, Tercero J, Carrero E, Hurtado P, Hervias A, Gracia I, Caral L, de Riva N, Valero R. ProSeal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients: A Randomized Clinical Trial. J Neurosurg Anesthesiol. 2015 Jul;27(3):194-202. doi: 10.1097/ANA.0000000000000108. PMID 25121397
• Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52. PMID 15385385
• Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28. PMID 19864308
• Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x. PMID 16095449
• Natalini G, Lanza G, Rosano A, Dell'Agnolo P, Bernardini A. Standard Laryngeal Mask Airway and LMA-ProSeal during laparoscopic surgery. J Clin Anesth. 2003 Sep;15(6):428-32. doi: 10.1016/s0952-8180(03)00085-0. PMID 14652119

Identifiers

NCT: NCT02708836 · 00004373

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗