Verbal Stimulation of Orientation on Emergence Agitation

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05105178

Collaborator

(none)

126

Enrollment

Arms

4.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Delirium	Other: Giving orientation with headphones Other: Emergence as usual with headphones	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 26, 2021

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of emergence agitation at operating room (OR) [20 minutes after anesthesia emergence]
Ricker sedation agitated scale ≥5

Secondary Outcome Measures

Incidence of emergence agitation at PACU [30 minutes after PACU adminstration]
Ricker sedation agitated scale ≥5
Incidence of high-risk emergence agitation [30 minutes after PACU adminstration]
Ricker sedation agitated scale =7
Time to emergence [20 minutes after anesthesia emergence]
Time from anesthetics off to eye opening/extubation/discharge from OR
Bispectral index (BIS) [20 minutes after anesthesia emergence]
BIS value at eye opening/extubation/discharge from OR
Postoperative Pain [10/20/30 minutes after PACU administation]
NRS score (0-11) of pain
Incidence of postoperative delirium [Postoperative 24 hours]
Delirium scale (CAM)
Postoperative quality of recovery [Postoperative 24 hours]
Korean version of quality of recovery-15
Postoperative opioid consumption [30 minutes after PACU adminstration / Postoperative 24 hours]
Postoperative opioid requirement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing robot-assisted laparoscopic prostatectomy or robot-assisted gynecological surgeries

Exclusion Criteria:

Day surgery
BMI ≥35
Neurocognitive impairment
Psychological drug intake
Experience of general anesthesia or sedation within 1 month

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bo Rim Kim, Clinical assistant professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05105178

Other Study ID Numbers:

21082521254

First Posted:

Nov 3, 2021

Last Update Posted:

Nov 3, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bo Rim Kim, Clinical assistant professor, Seoul National University Hospital

Emergence delirium, Emergence agitation, Orientation

Additional relevant MeSH terms:

Delirium

Psychomotor Agitation

Emergence Delirium

Study Results

No Results Posted as of Nov 3, 2021