Verbal Stimulation of Orientation on Emergence Agitation

Not Applicable

Completed

• Conditions: Emergence Delirium
• Interventions: Other: Emergence as usual with headphones; Other: Giving orientation with headphones

• Registration Number: NCT05105178
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-03
• Study Start: 2021-11-09
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-27
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Name	Emergence as usual with headphones	As usual, patient is recovered from general anesthesia with his/her name called.
Orientation	Giving orientation with headphones	Information of orientation (time, place, patient's own name) is repeatedly provided during emergence.

Primary Outcome Measures

Name	Time	Method
Incidence of emergence agitation at operating room (OR)	20 minutes after anesthesia emergence	Riker sedation agitated scale ≥5

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of