AnesthesiaNCT04331756
Use of Tragus Pressure in Guiding Emergence From Anaesthesia
A study testing Guiding Emergence From Anaesthesia With Tragus Pressure and Guiding Emergence From Anaesthesia Without Tragus Pressure in people with Anesthesia, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The aims of this study is to evaluate the effectiveness of tragus pressure application in predicting or facilitating recovery from general anaesthesia, and compare the reliability of tragus pressure guided recovery/ emergence from anaesthesia to conventional modes of recovery Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Guiding Emergence From Anaesthesia With Tragus Pressure and Guiding Emergence From Anaesthesia Without Tragus Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2017to 19 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 and 2
- Surgeries with no risk of aspiration
- Patients with laryngeal mask airway (LMA) insitu on arrival in the PACU
- Surgery duration < 4 hours
Who cannot join
- ASA 3 and 4
- Organ failure with decompensation : Eg Heart failure, renal failure, liver failure
- History of psychiatric illness or medications for mood control
- Pregnancy
- Patients for neurosurgery or GCS <12/15
- LMA used for failed intubation or difficult airway protocol
- Patients with no LMA on arrival in the PACU
- Patients who are awake with LMA/ Responding to call on arrival at PACU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Tragus Pressure in Guiding Emergence From Anaesthesia- a Randomised Controlled Trial
The aims of this study is to evaluate the effectiveness of tragus pressure application in predicting or facilitating recovery from general anaesthesia, and compare the reliability of tragus pressure guided recovery/ emergence from anaesthesia to conventional modes of recovery
Read the detailed description
More than 70% of general anaesthesia are now performed with laryngeal mask (LMA) as the airway support device with state of the art intra-operative monitoring such as end tidal inhalational anaesthetic agent concentration and fronto-temporal electroencephalographic waves analysis such as the Bispectral index score (BIS) and entropy. The use of LMAs have promised rapid turnover allowing more patients to be operated in the limited operating theatres' time. This comes with the additional price of losing the continuity of advanced monitoring devices in the post anaesthesia units, the best being end tidal carbon dioxide analysis. When patients are brought to the PACU, much of the monitoring of emergence from anaesthesia is fairly done through clinical measures such as motor activity, response to auditory stimuli, tactile taps on shoulder and occasional nociceptive stimuli such as sternal rub. The timing of the responsiveness of these stimuli is unknown and nursing support teams are unable to suggest a frame of time on when the patient would recover. One of the main reasons for this unpredictability is that the recovery is not planned based on the last recorded end tidal anaesthetic agent concentration before leaving the operating theatre to be shifted to PACU, but by an approximation of time since the patient has arrived in PACU and by early signs of recovery such as appearance of forehead wrinkles or motor activities. The incidence of airway events such as laryngospasm, obstruction after removal of airway devices, desaturations from resedation/ apnea and rescue measures such as reintubation/ ambu ventilation needed globally and from our local data is up to 1-5%. The incidence is higher with children and patients with reactive airways, obesity and associated complicating comorbidities. Using BIS monitoring and end tidal agent analysis for each of the 18 post anaesthesia care unit bays for recovering patients scientifically is not a cost-effective initiative. The tragus pressure technique has been known to be appropriate stimuli that has adequate stimulation of reticular activating system (RAS) without producing nociception that can trigger airway events such a laryngospasm. Physiological sleep studies have quoted that tragus pressure can contribute to arousal without causing vagotonic response that is known to occur from 'startle response' or sudden emergence. Through this study we propose to evaluate the consistency in predictability of recovery from general anaesthesia and deep sedation with Ramsay score 3 through application of tragus pressure. The presence of reflex pupillary dilatation and early signs of recovery such as swallowing, gentle grimace and minor peripheral motor movements, we propose, gives a predictable plane of recovery from anaesthesia where the LMAs are removed safely without treading the dreaded stage 2 of excitability of anaesthesia. The proposed method also allows for continued responsiveness of patient with coherent verbal responses to auditory stimuli after safe removal of the airway, thereby minimizing the incidence of airway complication and hence the interventions required for the same. The continued alert responsiveness of the patient also allows for the post anaesthesia unit team to attend to other patients who might need more immediate care.
- Conditions
- Anesthesia
- Being tested
- Guiding Emergence From Anaesthesia With Tragus Pressure, Guiding Emergence From Anaesthesia Without Tragus Pressure
- Keywords
- Anaesthesia Emergence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guiding Emergence From Anaesthesia With Tragus PressureProcedure or surgery
Use of tragus pressure in guiding patients from emergence from anaesthesia post-surgery
Guiding Emergence From Anaesthesia Without Tragus PressureProcedure or surgery
Usual clinical routine practice in guiding patients from emergence from anaesthesia post-surgery
| Study group | Role | What they receive |
|---|---|---|
| Guiding Emergence From Anaesthesia Without Tragus Pressure | Other | Monitoring of patients and removal of laryngeal mask airway (LMA) as per routine practice in post anaesthesia care unit (PACU) Receives: Procedure: Guiding Emergence From Anaesthesia Without Tragus Pressure |
| Guiding Emergence From Anaesthesia With Tragus Pressure | Experimental | Tragus pressure documentation of planes of emergence from anaesthesia - regular 3-5 minutes follow up with Tragus pressure till removal of airway device or rejection of it by patient Receives: Procedure: Guiding Emergence From Anaesthesia With Tragus Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in time and ease of LMA removal between study and control group
To compare the reliability of tragus pressure guided emergence from anaesthesia to conventional modes of recovery, studied by the timing and ease of removal of LMA.
Measured: Postoperatively in PACU from a minimum of 30 minutes till safe recovery from anaesthesia (approximately 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jul 2017
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashokka Balakrishnan, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331756
- Sponsor's protocol ID
- 2017/00071
- Other IDs
- 2017
- Status last verified
- Oct 2021
- First submitted
- 26 Mar 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhaskar SB. Emergence from anaesthesia: Have we got it all smoothened out? Indian J Anaesth. 2013 Jan;57(1):1-3. doi: 10.4103/0019-5049.108549. No abstract available.
PubMed 23716758Brown EN, Purdon PL, Van Dort CJ. General anesthesia and altered states of arousal: a systems neuroscience analysis. Annu Rev Neurosci. 2011;34:601-28. doi: 10.1146/annurev-neuro-060909-153200.
PubMed 21513454Academy of Medical Royal Colleges. Safe Sedation for Healthcare Procedures. Standards and Guidance. London: Academy of Medical Royal Colleges, 2013. http://www.aomrc.org.uk/doc_view/9737-safesedation- practice-for-healthcare-procedures-standards-and-guidance
Buchanan FF, Myles PS, Cicuttini F. Effect of patient sex on general anaesthesia and recovery. Br J Anaesth. 2011 Jun;106(6):832-9. doi: 10.1093/bja/aer094. Epub 2011 May 9.
PubMed 21558068Checketts MR, Alladi R, Ferguson K, Gemmell L, Handy JM, Klein AA, Love NJ, Misra U, Morris C, Nathanson MH, Rodney GE, Verma R, Pandit JJ; Association of Anaesthetists of Great Britain and Ireland. Recommendations for standards of monitoring during anaesthesia and recovery 2015: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2016 Jan;71(1):85-93. doi: 10.1111/anae.13316. Epub 2015 Nov 19.
PubMed 26582586Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
PubMed 19411668Leslie K, Allen ML, Hessian EC, Peyton PJ, Kasza J, Courtney A, Dhar PA, Briedis J, Lee S, Beeton AR, Sayakkarage D, Palanivel S, Taylor JK, Haughton AJ, O'Kane CX. Safety of sedation for gastrointestinal endoscopy in a group of university-affiliated hospitals: a prospective cohort study. Br J Anaesth. 2017 Jan;118(1):90-99. doi: 10.1093/bja/aew393.
PubMed 28039246Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
PubMed 15172773Pandit JJ, Cook TM. National Institute for Clinical Excellence guidance on measuring depth of anaesthesia: limitations of EEG-based technology. Br J Anaesth. 2013 Mar;110(3):325-8. doi: 10.1093/bja/aet006. No abstract available.
PubMed 23404965Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003843. doi: 10.1002/14651858.CD003843.pub2.
PubMed 17943802Singh R, Kharbanda M, Sood N, Mahajan V, Chatterji C. Comparative evaluation of incidence of emergence agitation and post-operative recovery profile in paediatric patients after isoflurane, sevoflurane and desflurane anaesthesia. Indian J Anaesth. 2012 Mar;56(2):156-61. doi: 10.4103/0019-5049.96325.
PubMed 22701207
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tragus Pressure in Guiding Emergence From Anaesthesia- a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04331756
- Acronym / sponsor ID
- 2017/00071
- Conditions
- Anesthesia
- Keywords
- Anaesthesia Emergence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 2 Apr 2020 (actual)
- 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.
The aims of this study is to evaluate the effectiveness of tragus pressure application in predicting or facilitating recovery from general anaesthesia, and compare the reliability of tragus pressure guided recovery/ emergence from anaesthesia to conventional modes of recovery
Detailed description
More than 70% of general anaesthesia are now performed with laryngeal mask (LMA) as the airway support device with state of the art intra-operative monitoring such as end tidal inhalational anaesthetic agent concentration and fronto-temporal electroencephalographic waves analysis such as the Bispectral index score (BIS) and entropy. The use of LMAs have promised rapid turnover allowing more patients to be operated in the limited operating theatres' time. This comes with the additional price of losing the continuity of advanced monitoring devices in the post anaesthesia units, the best being end tidal carbon dioxide analysis. When patients are brought to the PACU, much of the monitoring of emergence from anaesthesia is fairly done through clinical measures such as motor activity, response to auditory stimuli, tactile taps on shoulder and occasional nociceptive stimuli such as sternal rub. The timing of the responsiveness of these stimuli is unknown and nursing support teams are unable to suggest a frame of time on when the patient would recover. One of the main reasons for this unpredictability is that the recovery is not planned based on the last recorded end tidal anaesthetic agent concentration before leaving the operating theatre to be shifted to PACU, but by an approximation of time since the patient has arrived in PACU and by early signs of recovery such as appearance of forehead wrinkles or motor activities. The incidence of airway events such as laryngospasm, obstruction after removal of airway devices, desaturations from resedation/ apnea and rescue measures such as reintubation/ ambu ventilation needed globally and from our local data is up to 1-5%. The incidence is higher with children and patients with reactive airways, obesity and associated complicating comorbidities. Using BIS monitoring and end tidal agent analysis for each of the 18 post anaesthesia care unit bays for recovering patients scientifically is not a cost-effective initiative. The tragus pressure technique has been known to be appropriate stimuli that has adequate stimulation of reticular activating system (RAS) without producing nociception that can trigger airway events such a laryngospasm. Physiological sleep studies have quoted that tragus pressure can contribute to arousal without causing vagotonic response that is known to occur from 'startle response' or sudden emergence. Through this study we propose to evaluate the consistency in predictability of recovery from general anaesthesia and deep sedation with Ramsay score 3 through application of tragus pressure. The presence of reflex pupillary dilatation and early signs of recovery such as swallowing, gentle grimace and minor peripheral motor movements, we propose, gives a predictable plane of recovery from anaesthesia where the LMAs are removed safely without treading the dreaded stage 2 of excitability of anaesthesia. The proposed method also allows for continued responsiveness of patient with coherent verbal responses to auditory stimuli after safe removal of the airway, thereby minimizing the incidence of airway complication and hence the interventions required for the same. The continued alert responsiveness of the patient also allows for the post anaesthesia unit team to attend to other patients who might need more immediate care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guiding Emergence From Anaesthesia Without Tragus Pressure | Other | Procedure: Guiding Emergence From Anaesthesia Without Tragus PressureMonitoring of patients and removal of laryngeal mask airway (LMA) as per routine practice in post anaesthesia care unit (PACU) |
| Guiding Emergence From Anaesthesia With Tragus Pressure | Experimental | Procedure: Guiding Emergence From Anaesthesia With Tragus PressureTragus pressure documentation of planes of emergence from anaesthesia - regular 3-5 minutes follow up with Tragus pressure till removal of airway device or rejection of it by patient |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1 and 2
- Surgeries with no risk of aspiration
- Patients with laryngeal mask airway (LMA) insitu on arrival in the PACU
- Surgery duration < 4 hours
Key exclusion criteria (8 listed)
- ASA 3 and 4
- Organ failure with decompensation : Eg Heart failure, renal failure, liver failure
- History of psychiatric illness or medications for mood control
- Pregnancy
- Patients for neurosurgery or GCS <12/15
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 |
|---|---|---|
| Guiding Emergence From Anaesthesia With Tragus PressureUse of tragus pressure in guiding patients from emergence from anaesthesia post-surgery | Procedure or surgery | Guiding Emergence From Anaesthesia With Tragus Pressure |
| Guiding Emergence From Anaesthesia Without Tragus PressureUsual clinical routine practice in guiding patients from emergence from anaesthesia post-surgery | Procedure or surgery | Guiding Emergence From Anaesthesia Without Tragus Pressure |
Primary outcome
Differences in time and ease of LMA removal between study and control group
Time frame: Postoperatively in PACU from a minimum of 30 minutes till safe recovery from anaesthesia (approximately 1 hour)
To compare the reliability of tragus pressure guided emergence from anaesthesia to conventional modes of recovery, studied by the timing and ease of removal of LMA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 23716758Bhaskar SB. Emergence from anaesthesia: Have we got it all smoothened out? Indian J Anaesth. 2013 Jan;57(1):1-3. doi: 10.4103/0019-5049.108549. No abstract available.
- Background: PubMed 21513454Brown EN, Purdon PL, Van Dort CJ. General anesthesia and altered states of arousal: a systems neuroscience analysis. Annu Rev Neurosci. 2011;34:601-28. doi: 10.1146/annurev-neuro-060909-153200.
- BackgroundAcademy of Medical Royal Colleges. Safe Sedation for Healthcare Procedures. Standards and Guidance. London: Academy of Medical Royal Colleges, 2013. http://www.aomrc.org.uk/doc_view/9737-safesedation- practice-for-healthcare-procedures-standards-and-guidance
- Background: PubMed 21558068Buchanan FF, Myles PS, Cicuttini F. Effect of patient sex on general anaesthesia and recovery. Br J Anaesth. 2011 Jun;106(6):832-9. doi: 10.1093/bja/aer094. Epub 2011 May 9.
- Background: PubMed 26582586Checketts MR, Alladi R, Ferguson K, Gemmell L, Handy JM, Klein AA, Love NJ, Misra U, Morris C, Nathanson MH, Rodney GE, Verma R, Pandit JJ; Association of Anaesthetists of Great Britain and Ireland. Recommendations for standards of monitoring during anaesthesia and recovery 2015: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2016 Jan;71(1):85-93. doi: 10.1111/anae.13316. Epub 2015 Nov 19.
- Background: PubMed 19411668Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
- Background: PubMed 28039246Leslie K, Allen ML, Hessian EC, Peyton PJ, Kasza J, Courtney A, Dhar PA, Briedis J, Lee S, Beeton AR, Sayakkarage D, Palanivel S, Taylor JK, Haughton AJ, O'Kane CX. Safety of sedation for gastrointestinal endoscopy in a group of university-affiliated hospitals: a prospective cohort study. Br J Anaesth. 2017 Jan;118(1):90-99. doi: 10.1093/bja/aew393.
- Background: PubMed 15172773Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
- Background: PubMed 23404965Pandit JJ, Cook TM. National Institute for Clinical Excellence guidance on measuring depth of anaesthesia: limitations of EEG-based technology. Br J Anaesth. 2013 Mar;110(3):325-8. doi: 10.1093/bja/aet006. No abstract available.
- Background: PubMed 17943802Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003843. doi: 10.1002/14651858.CD003843.pub2.
- Background: PubMed 22701207Singh R, Kharbanda M, Sood N, Mahajan V, Chatterji C. Comparative evaluation of incidence of emergence agitation and post-operative recovery profile in paediatric patients after isoflurane, sevoflurane and desflurane anaesthesia. Indian J Anaesth. 2012 Mar;56(2):156-61. doi: 10.4103/0019-5049.96325.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ashokka Balakrishnan principal investigator
National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guiding Emergence From Anaesthesia With Tragus Pressure and Guiding Emergence From Anaesthesia Without Tragus Pressure in people with Anesthesia, run by National University Hospital, Singapore at 1 site in Singapore.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 26 Oct 2021. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in time and ease of LMA removal between study and control group (time frame: Postoperatively in PACU from a minimum of 30 minutes till safe recovery from anaesthesia (approximately 1 hour)). 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 NCT04331756, which also lists 11 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 26 Oct 2021.