Verbal Stimulation of Orientation on Emergence Agitation

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05105178
• Other study ID #: 21082521254
• Status: Completed
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: April 27, 2022

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 27, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ?

• 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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Psychomotor Agitation

Intervention

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
• Emergence as usual with headphones
During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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