NCT05105178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 22, 2021

Last Update Submit

October 10, 2022

Conditions

Emergence Delirium

Keywords

Emergence delirium, Emergence agitation, Orientation

Outcome Measures

Primary Outcomes (1)

  • Incidence of emergence agitation at operating room (OR)

    Riker sedation agitated scale ≥5

    20 minutes after anesthesia emergence

Secondary Outcomes (11)

  • Incidence of dangerous emergence agitation

    20 minutes after anesthesia emergence

  • maximal Riker sedation agitated scale during emergence

    20 minutes after anesthesia emergence

  • Time to emergence

    20 minutes after anesthesia emergence

  • Bispectral index (BIS)

    20 minutes after anesthesia emergence

  • Incidence of emergence agitation at PACU

    30 minutes after PACU adminstration

  • +6 more secondary outcomes

Study Arms (2)

Orientation

EXPERIMENTAL

Information of orientation (time, place, patient's own name) is repeatedly provided during emergence.

Other: Giving orientation with headphones

Name

ACTIVE COMPARATOR

As usual, patient is recovered from general anesthesia with his/her name called.

Other: Emergence as usual with headphones

Interventions

Giving orientation with headphonesOTHER

During emergence, recorded voice of an investigator giving Information of orientation (time, place, patient's own name) is repeatedly played from noise-cancelling headphones

Orientation
Emergence as usual with headphonesOTHER

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

Name

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective laparoscopic or robot-assisted abdominal surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Lee S, Sohn JY, Hwang IE, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of a repeated verbal reminder of orientation on emergence agitation after general anaesthesia for minimally invasive abdominal surgery: a randomised controlled trial. Br J Anaesth. 2023 Apr;130(4):439-445. doi: 10.1016/j.bja.2022.12.009. Epub 2023 Jan 23.

    PMID: 36697272DERIVED

MeSH Terms

Conditions

Emergence DeliriumOrientation, Spatial

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersSpatial BehaviorBehavior

Study Officials

  • Bo Rim Kim, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 3, 2021

Study Start

November 9, 2021

Primary Completion

April 20, 2022

Study Completion

April 27, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)