Limit Emergence Phenomena After General AnesthesiaLEPAGANCT02708836
Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique
A study testing Induction of anesthesia, Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask] and Laryngoscopy and placement of ETT in people with Limit Emergence Phenomena After General Anesthesia, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limit Emergence Phenomena After General Anesthesia
- What is being tested?
- Induction of anesthesia, Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask] and Laryngoscopy and placement of ETT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- Patients undergoing elective laparoscopic surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Health - Hershey Medical Center
Hershey, Pennsylvania, 17033
Arne Budde, MD, 7175316140, abudde@pennstatehealth.psu.edu
Arne Budde, MD
About this study
Official title: Limiting Emergence Phenomena After General Anesthesia for Laparoscopic Surgery With Combined Laryngeal Mask Airway and Endotracheal Tube Airway Management Technique
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.
Read the 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.
- Being tested
- Induction of anesthesia, Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask], Laryngoscopy and placement of ETT, Ventilation via the ETT, Removal of the ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of anesthesiaProcedure or surgery
At the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent
Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]Device
By standard method. Sizing at the discretion of the primary anesthesiologist.
Laryngoscopy and placement of ETTDevice
Via direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien)
Ventilation via the ETTProcedure or surgery
Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
Removal of the ETTProcedure or surgery
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.
Intubation of the trachea through the LMAProcedure or surgery
With ETT using fiberoptic bronchoscope guidance.
Ventilation via the LMAProcedure or surgery
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.
Emergence from anesthesiaProcedure or surgery
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").
| Study group | Role | What they receive |
|---|---|---|
| ETT only | Active comparator | Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence. Receives: Procedure: Induction of anesthesia; Device: Laryngoscopy and placement of ETT; Procedure: Ventilation via the ETT; Procedure: Removal of the ETT; Procedure: Emergence from anesthesia |
| 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. Receives: Procedure: Induction of anesthesia; Device: Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]; Procedure: Ventilation via the ETT; Procedure: Removal of the ETT; Procedure: Intubation of the trachea through the LMA; Procedure: Ventilation via the LMA; Procedure: Emergence from anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate pressure product during emergence
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.
Measured: Intraoperative
Secondary outcomes (10)
Time to successful ventilation via ETT
From administration of induction medication until ETT placement confirmed via capnography.
Measured: Intraoperative
Change in rate pressure product during induction of anesthesia and intubation
Difference in heart rate multiplied by systolic blood pressure measured during the ~5 minutes prior to induction of anesthesia and the ~5 minutes after placement 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 placement 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 placement of the airway device.
Measured: Intraoperative
Success rate of ventilation with LMA after extubation of trachea
After deflation of the pneumoperitoneum, the ETT will be removed and ventilation will be continued through the LMA.
Success will be graded as follows:
- Adequate ventilation via LMA without need for adjustment.
- Adequate ventilation via LMA after adjustment of LMA.
- Inadequate ventilation via LMA. Unable to successfully re-seat LMA and need to re-intubate.
Measured: Intraoperative
Presence/ severity of cough during prior to removal of airway device
During 5 minutes prior to removal of airway device.
Cough will be graded as follows:
None Mild = 1 episode of unsustained coughing (< 5 s) Moderate = More than 1 episode of unsustained (<5 s) coughing Severe = Sustained bout(s) of coughing (>5 s) http://www.ncbi.nlm.nih.gov/pubmed/15385385 - (5. Minogue 2004)
Measured: Intraoperative
Presence/ severity of cough during after removal of airway device
During 5 minutes after removal of airway device.
Cough will be graded as follows:
None Mild = 1 episode of unsustained coughing (< 5 s) Moderate = More than 1 episode of unsustained (<5 s) coughing Severe = Sustained bout(s) of coughing (>5 s) http://www.ncbi.nlm.nih.gov/pubmed/15385385 - (5. Minogue 2004)
Measured: Intraoperative
Total opioids (morphine equivalents) administered intraoperatively
From pre-induction until patient hand-off to post-anesthesia care unit team. Total intraoperative narcotics will be converted to morphine equivalents.
Measured: Intraoperative
LMA cuff pressures when inflated to seal
After placement of LMA and LMA cuff inflated to seal. Pressure in the cuff will be measured and then deflated to pressures of 50-60 cmH20.
Measured: Intraoperative
LMA cuff pressures prior to removal of ETT.
After deflation of the pneumoperitoneum. Pressure in the cuff will be measured and then deflated to pressures of 50-60 cmH20.
Measured: Intraoperative
Presence of oropharyngeal sensory or motor nerve palsy.
Postoperative day 3-5. A phone call will be made to determine the number of participants with the presence of any oropharyngeal numbness / paresthesias, hoarseness (recurrent laryngeal n. - Lehnert, 2008), dysphagia/ dysarthria (hypoglossal n. - Takahoko, 2014 \& Shah, 2015), decreased sensation and sense of taste (lingual n. - El Toukhy, 2012) that could be indicative of a neuropraxia versus nerve palsy.
Measured: Up to 1 week
Presence of sore throat.
Postoperative day 3-5. A phone call will be made to determine the number of participants with sore throat (subjectively rated as none, mild, or severe).
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Jan 2020
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Limit Emergence Phenomena After General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ambu A/S
- Responsible party
- Principal investigator, Taylor Anspach, Milton S. Hershey Medical Center
- Investigators
- Arne Budde, MD, Principal investigator, Penn State M.S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708836
- Sponsor's protocol ID
- 00004373
- Acronym
- LEPAGA
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2016
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will be stored in REDCap, a HIPPA compliant secured and encrypted electronic database.
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.
PubMed 22321104Atkinson 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.
PubMed 9709138Perello-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.
PubMed 25121397Minogue 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.
PubMed 15385385Nho 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.
PubMed 19864308Guler 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.
PubMed 16095449Natalini 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.
PubMed 14652119Beleña JM, Núñez M, Gracia JL, Pérez JL, Yuste J. The Laryngeal Mask Airway Supreme™: safety and efficacy during gynaecological laparoscopic surgery. Southern African Journal of Anaesthesia and Analgesia 18: 143-7, 2012.
Carron M, Veronese S, Gomiero W, Foletto M, Nitti D, Ori C, Freo U. Hemodynamic and hormonal stress responses to endotracheal tube and ProSeal Laryngeal Mask Airway for laparoscopic gastric banding. Anesthesiology. 2012 Aug;117(2):309-20. doi: 10.1097/ALN.0b013ef31825b6a80.
PubMed 22614132Bernardini A, Natalini G. Risk of pulmonary aspiration with laryngeal mask airway and tracheal tube: analysis on 65 712 procedures with positive pressure ventilation. Anaesthesia. 2009 Dec;64(12):1289-94. doi: 10.1111/j.1365-2044.2009.06140.x. Epub 2009 Oct 23.
PubMed 19860753Nair I, Bailey PM. Use of the laryngeal mask for airway maintenance following tracheal extubation. Anaesthesia. 1995 Feb;50(2):174-5. doi: 10.1111/j.1365-2044.1995.tb15104.x. No abstract available.
PubMed 7710032Timmermann A. Supraglottic airways in difficult airway management: successes, failures, use and misuse. Anaesthesia. 2011 Dec;66 Suppl 2:45-56. doi: 10.1111/j.1365-2044.2011.06934.x.
PubMed 22074079Takahoko K, Iwasaki H, Sasakawa T, Suzuki A, Matsumoto H, Iwasaki H. Unilateral hypoglossal nerve palsy after use of the laryngeal mask airway supreme. Case Rep Anesthesiol. 2014;2014:369563. doi: 10.1155/2014/369563. Epub 2014 Aug 31.
PubMed 25254120Lehnert B, Prescher A, Neuschaefer-Rube C. Is laryngeal mask airway-related vocal chord palsy always laryngeal mask airway-related? Br J Anaesth. 2008 Dec;101(6):882. doi: 10.1093/bja/aen304. No abstract available.
PubMed 19004921
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limiting Emergence Phenomena After General Anesthesia for Laparoscopic Surgery With Combined Laryngeal Mask Airway and Endotracheal Tube Airway Management Technique
- ClinicalTrials.gov ID
- NCT02708836
- Acronym / sponsor ID
- LEPAGA / 00004373
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Ambu A/S
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETT only | Active comparator | Procedure: Induction of anesthesia, Device: Laryngoscopy and placement of ETT, Procedure: Ventilation via the ETT, Procedure: Removal of the ETT, Procedure: Emergence from anesthesiaEndotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence. |
| Combined ETT/LMA technique | Experimental | Procedure: Induction of anesthesia, Device: Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask], Procedure: Ventilation via the ETT, Procedure: Removal of the ETT, Procedure: Intubation of the trachea through the LMA, Procedure: Ventilation via the LMA, Procedure: Emergence from anesthesiaPlacement 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-3
- Patients undergoing elective laparoscopic surgery
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of anesthesiaAt the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent | Procedure or surgery | Combined ETT/LMA technique, ETT only |
| Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]By standard method. Sizing at the discretion of the primary anesthesiologist. | Device | Combined ETT/LMA technique |
| Laryngoscopy and placement of ETTVia direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien) | Device | ETT only |
| Ventilation via the ETTVentilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist. | Procedure or surgery | Combined ETT/LMA technique, ETT only |
| Removal of the ETTEither 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 or surgery | Combined ETT/LMA technique, ETT only |
| Intubation of the trachea through the LMAWith ETT using fiberoptic bronchoscope guidance. | Procedure or surgery | Combined ETT/LMA technique |
| Ventilation via the LMAAfter 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 or surgery | Combined ETT/LMA technique |
| Emergence from anesthesiaAt 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"). | Procedure or surgery | Combined ETT/LMA technique, ETT only |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Results publication: PubMed 22321104Difficult 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.
- Results publicationAtkinson RS, Rushman GB, Alfred Lee J: A Synopsis of Anaesthesia, 10th edition. Butterworth-Heinemann Ltd, 1987, pp 165-9
- Results publication: PubMed 9709138Koga 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.
- Results publication: PubMed 25121397Perello-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.
- Results publication: PubMed 15385385Minogue 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.
- Results publication: PubMed 19864308Nho 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.
- Results publication: PubMed 16095449Guler 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.
- Results publication: PubMed 14652119Natalini 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.
- Results publicationBeleña JM, Núñez M, Gracia JL, Pérez JL, Yuste J. The Laryngeal Mask Airway Supreme™: safety and efficacy during gynaecological laparoscopic surgery. Southern African Journal of Anaesthesia and Analgesia 18: 143-7, 2012.
- Results publication: PubMed 22614132Carron M, Veronese S, Gomiero W, Foletto M, Nitti D, Ori C, Freo U. Hemodynamic and hormonal stress responses to endotracheal tube and ProSeal Laryngeal Mask Airway for laparoscopic gastric banding. Anesthesiology. 2012 Aug;117(2):309-20. doi: 10.1097/ALN.0b013ef31825b6a80.
- Results publication: PubMed 19860753Bernardini A, Natalini G. Risk of pulmonary aspiration with laryngeal mask airway and tracheal tube: analysis on 65 712 procedures with positive pressure ventilation. Anaesthesia. 2009 Dec;64(12):1289-94. doi: 10.1111/j.1365-2044.2009.06140.x. Epub 2009 Oct 23.
- Results publication: PubMed 7710032Nair I, Bailey PM. Use of the laryngeal mask for airway maintenance following tracheal extubation. Anaesthesia. 1995 Feb;50(2):174-5. doi: 10.1111/j.1365-2044.1995.tb15104.x. No abstract available.
- Individual participant dataSharing planned: No. IPD will be stored in REDCap, a HIPPA compliant secured and encrypted electronic database.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arne Budde, MD principal investigator
Penn State M.S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of anesthesia, Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask] and Laryngoscopy and placement of ETT in people with Limit Emergence Phenomena After General Anesthesia, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arne Budde, MD (717-531-6140, abudde@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate pressure product during emergence (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708836, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.