Use of Tragus Pressure in Guiding Emergence From Anaesthesia

NCT04331756 | Completed

• 1 other identifier: 2017/00071
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anesthesia

Keywords

Anaesthesia Emergence

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperatively in PACU from a minimum of 30 minutes till safe recovery from anaesthesia (approximately 1 hour)

Study Arms (2)

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)

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

Procedure: Guiding Emergence From Anaesthesia With Tragus Pressure

Interventions

Guiding Emergence From Anaesthesia With Tragus Pressure PROCEDURE

Use of tragus pressure in guiding patients from emergence from anaesthesia post-surgery

Guiding Emergence From Anaesthesia With Tragus Pressure

Guiding Emergence From Anaesthesia Without Tragus Pressure PROCEDURE

Usual clinical routine practice in guiding patients from emergence from anaesthesia post-surgery

Guiding Emergence From Anaesthesia Without Tragus Pressure

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 110974, Singapore

Location

Related Publications (11)

• 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.

  PMID: 23716758 BACKGROUND

• Brown 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.

  PMID: 21513454 BACKGROUND

• Academy 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

• 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.

  PMID: 21558068 BACKGROUND

• Checketts 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.

  PMID: 26582586 BACKGROUND

• Lee 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.

  PMID: 19411668 BACKGROUND

• Leslie 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.

  PMID: 28039246 BACKGROUND

• Myles 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.

  PMID: 15172773 BACKGROUND

• Pandit 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.

  PMID: 23404965 BACKGROUND

• Punjasawadwong 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.

  PMID: 17943802 BACKGROUND

• Singh 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.

  PMID: 22701207 BACKGROUND

Study Officials

• Ashokka Balakrishnan

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 2, 2020
• Study Start: July 1, 2017
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)