Verbal Stimulation of Orientation on Emergence Agitation

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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Delirium
• Intervention / Treatment: Other: Giving orientation with headphones; Other: Emergence as usual with headphones

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Bo Rim Kim, M.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Emergence delirium, Emergence agitation, Orientation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium
• Other Study ID Numbers: 21082521254

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