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Use of Tragus Pressure in Guiding Emergence From Anaesthesia

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ClinicalTrials.gov Identifier: NCT04331756
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE March 26, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date April 2, 2020
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Tragus Pressure in Guiding Emergence From Anaesthesia
Official Title  ICMJE Use of Tragus Pressure in Guiding Emergence From Anaesthesia- a Randomised Controlled Trial
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Procedure: Guiding Emergence From Anaesthesia With Tragus Pressure
    Use of tragus pressure in guiding patients from emergence from anaesthesia post-surgery
  • Procedure: Guiding Emergence From Anaesthesia Without Tragus Pressure
    Usual clinical routine practice in guiding patients from emergence from anaesthesia post-surgery
Study Arms  ICMJE
  • 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)
    Intervention: Procedure: Guiding Emergence From Anaesthesia Without Tragus Pressure
  • 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
    Intervention: Procedure: Guiding Emergence From Anaesthesia With Tragus Pressure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2020)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashokka Balakrishnan 97118855 ashokka_balakrishnan@nuhs.edu.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04331756
Other Study ID Numbers  ICMJE 2017/00071
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ashokka Balakrishnan National University Health System
PRS Account National University Hospital, Singapore
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP