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Verbal Stimulation of Orientation on Emergence Agitation

Primary Purpose

Emergence Delirium

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Giving orientation with headphones
Emergence as usual with headphones
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium focused on measuring Emergence delirium, Emergence agitation, Orientation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Orientation

Name

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of emergence agitation at operating room (OR)
Riker sedation agitated scale ≥5

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2021
Last Updated
October 10, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05105178
Brief Title
Verbal Stimulation of Orientation on Emergence Agitation
Official Title
Effect of a Repeated Verbal Stimulation of Orientation on Emergence Agitation After General Anesthesia: a Randomized Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
Keywords
Emergence delirium, Emergence agitation, Orientation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orientation
Arm Type
Experimental
Arm Description
Information of orientation (time, place, patient's own name) is repeatedly provided during emergence.
Arm Title
Name
Arm Type
Active Comparator
Arm Description
As usual, patient is recovered from general anesthesia with his/her name called.
Intervention Type
Other
Intervention Name(s)
Giving orientation with headphones
Intervention Description
During emergence, recorded voice of an investigator giving Information of orientation (time, place, patient's own name) is repeatedly played from noise-cancelling headphones
Intervention Type
Other
Intervention Name(s)
Emergence as usual with headphones
Intervention Description
During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones
Primary Outcome Measure Information:
Title
Incidence of emergence agitation at operating room (OR)
Description
Riker sedation agitated scale ≥5
Time Frame
20 minutes after anesthesia emergence
Secondary Outcome Measure Information:
Title
Incidence of dangerous emergence agitation
Description
Riker sedation agitated scale =7
Time Frame
20 minutes after anesthesia emergence
Title
maximal Riker sedation agitated scale during emergence
Description
maximum value of Riker sedation agitated scale during emergence
Time Frame
20 minutes after anesthesia emergence
Title
Time to emergence
Description
Time from anesthetics off to eye opening/extubation/discharge from OR
Time Frame
20 minutes after anesthesia emergence
Title
Bispectral index (BIS)
Description
BIS value at desflurane discontinuation/verbal response/extubation
Time Frame
20 minutes after anesthesia emergence
Title
Incidence of emergence agitation at PACU
Description
Riker sedation agitated scale ≥5
Time Frame
30 minutes after PACU adminstration
Title
Incidence of postoperative delirium
Description
Delirium scale (CAM)
Time Frame
30 minutes after PACU adminstration / Postoperative 24 hours
Title
Postoperative Pain
Description
NRS score (0-11) of pain
Time Frame
10/20/30 minutes after PACU administation / Postoperative 24 hours
Title
PACU stay
Description
Length (hours) of PACU stay
Time Frame
up to 3 hours after PACU administration
Title
Postoperative opioid consumption
Description
Postoperative opioid requirement
Time Frame
30 minutes after PACU adminstration / Postoperative 24 hours
Title
Analgesics requirement
Description
Analgesics other than opioid requirement
Time Frame
Postoperative 24 hours
Title
Postoperative quality of recovery
Description
Korean version of quality of recovery-15
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Rim Kim, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Verbal Stimulation of Orientation on Emergence Agitation

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