Verbal Stimulation of Orientation on Emergence Agitation

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether information of the orientation such as time, place, and patient's own name can reduce emergence delirium after general anesthesia.

Official Title
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Effect of a Repeated Verbal Stimulation of Orientation on Emergence Agitation After General Anesthesia: a Randomized Double-blind Trial

Conditions
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Emergence Delirium

Intervention / Treatment
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* Other: Giving orientation with headphones
* Other: Emergence as usual with headphones


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective laparoscopic or robot-assisted abdominal surgery Exclusion Criteria: Patients' refusal Change in operation schedule American Society of Anaesthesiologists (ASA) physical status Ⅳ Day surgery BMI ≥35 Neurocognitive impairment, hearing disorder Psychological drug intake Experience of general anesthesia or sedation within 1 month Drop out Criteria Changes in operation schedule (e.g. unexpected collaborative surgery, conversion to laparotomy, delay of the schedule to night-duty hours) Significant protocol violation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orientation<br>Information of orientation (time, place, patient's own name) is repeatedly provided during emergence. | Other: Giving orientation with headphones<br>* During emergence, recorded voice of an investigator giving Information of orientation (time, place, patient's own name) is repeatedly played from noise-cancelling headphones<br>|
| Active Comparator: Name<br>As usual, patient is recovered from general anesthesia with his/her name called. | Other: Emergence as usual with headphones<br>* During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of emergence agitation at operating room (OR) | Riker sedation agitated scale ≥5 | 20 minutes after anesthesia emergence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dangerous emergence agitation | Riker sedation agitated scale =7 | 20 minutes after anesthesia emergence | 
| maximal Riker sedation agitated scale during emergence | maximum value of Riker sedation agitated scale during emergence | 20 minutes after anesthesia emergence | 
| Time to emergence | Time from anesthetics off to eye opening/extubation/discharge from OR | 20 minutes after anesthesia emergence | 
| Bispectral index (BIS) | BIS value at desflurane discontinuation/verbal response/extubation | 20 minutes after anesthesia emergence | 
| Incidence of emergence agitation at PACU | Riker sedation agitated scale ≥5 | 30 minutes after PACU adminstration | 
| Incidence of postoperative delirium | Delirium scale (CAM) | 30 minutes after PACU adminstration / Postoperative 24 hours | 
| Postoperative Pain | NRS score (0-11) of pain | 10/20/30 minutes after PACU administation / Postoperative 24 hours | 
| PACU stay | Length (hours) of PACU stay | up to 3 hours after PACU administration | 
| Postoperative opioid consumption | Postoperative opioid requirement | 30 minutes after PACU adminstration / Postoperative 24 hours | 
| Analgesics requirement | Analgesics other than opioid requirement | Postoperative 24 hours | 
| Postoperative quality of recovery | Korean version of quality of recovery-15 | Postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergence delirium, Emergence agitation, Orientation