Use of Tragus Pressure in Guiding Emergence From Anaesthesia

October 24, 2021 updated by: National University Hospital, Singapore

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 110974
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Guiding Emergence From Anaesthesia Without Tragus Pressure
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
Usual clinical routine practice in guiding patients from emergence from anaesthesia post-surgery
EXPERIMENTAL: Guiding Emergence From Anaesthesia With Tragus Pressure
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
Use of tragus pressure in guiding patients from emergence from anaesthesia post-surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperatively in PACU from a minimum of 30 minutes till safe recovery from anaesthesia (approximately 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Ashokka Balakrishnan, National University Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

March 19, 2021

Study Completion (ACTUAL)

March 19, 2021

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (ACTUAL)

April 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/00071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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