Emergence DeliriumNCT05105178
Verbal Stimulation of Orientation on Emergence Agitation
A study testing Giving orientation with headphones and Emergence as usual with headphones in people with Emergence Delirium, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Giving orientation with headphones and Emergence as usual with headphones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2021to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective laparoscopic or robot-assisted abdominal surgery
Who cannot join
- Patients' refusal
- Change in operation schedule
- American Society of Anaesthesiologists (ASA) physical status Ⅳ
- Day surgery
- BMI ≥35
- Neurocognitive impairment, hearing disorder
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Repeated Verbal Stimulation of Orientation on Emergence Agitation After General Anesthesia: a Randomized Double-blind Trial
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.
- Conditions
- Emergence Delirium
- Being tested
- Giving orientation with headphones, Emergence as usual with headphones
- Keywords
- Emergence delirium, Emergence agitation, Orientation
- Medical subject headings
- Emergence Delirium, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Emergence as usual with headphonesOther
During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones
| Study group | Role | What they receive |
|---|---|---|
| Orientation | Experimental | Information of orientation (time, place, patient's own name) is repeatedly provided during emergence. Receives: Other: Giving orientation with headphones |
| Name | Active comparator | As usual, patient is recovered from general anesthesia with his/her name called. Receives: Other: Emergence as usual with headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence agitation at operating room (OR)
Riker sedation agitated scale ≥5
Measured: 20 minutes after anesthesia emergence
Secondary outcomes (11)
Incidence of dangerous emergence agitation
Riker sedation agitated scale =7
Measured: 20 minutes after anesthesia emergence
maximal Riker sedation agitated scale during emergence
maximum value of Riker sedation agitated scale during emergence
Measured: 20 minutes after anesthesia emergence
Time to emergence
Time from anesthetics off to eye opening/extubation/discharge from OR
Measured: 20 minutes after anesthesia emergence
Bispectral index (BIS)
BIS value at desflurane discontinuation/verbal response/extubation
Measured: 20 minutes after anesthesia emergence
Incidence of emergence agitation at PACU
Riker sedation agitated scale ≥5
Measured: 30 minutes after PACU adminstration
Incidence of postoperative delirium
Delirium scale (CAM)
Measured: 30 minutes after PACU adminstration / Postoperative 24 hours
Postoperative Pain
NRS score (0-11) of pain
Measured: 10/20/30 minutes after PACU administation / Postoperative 24 hours
PACU stay
Length (hours) of PACU stay
Measured: up to 3 hours after PACU administration
Postoperative opioid consumption
Postoperative opioid requirement
Measured: 30 minutes after PACU adminstration / Postoperative 24 hours
Analgesics requirement
Analgesics other than opioid requirement
Measured: Postoperative 24 hours
Postoperative quality of recovery
Korean version of quality of recovery-15
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start9 Nov 2021
- Primary completion20 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Rim Kim, Seoul National University Hospital
- Investigators
- Bo Rim Kim, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105178
- Sponsor's protocol ID
- 21082521254
- Status last verified
- Oct 2022
- First submitted
- 22 Oct 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36697272
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Repeated Verbal Stimulation of Orientation on Emergence Agitation After General Anesthesia: a Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT05105178
- Acronym / sponsor ID
- 21082521254
- Conditions
- Emergence Delirium
- Keywords
- Emergence delirium, Emergence agitation, Orientation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orientation | Experimental | Other: Giving orientation with headphonesInformation of orientation (time, place, patient's own name) is repeatedly provided during emergence. |
| Name | Active comparator | Other: Emergence as usual with headphonesAs usual, patient is recovered from general anesthesia with his/her name called. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective laparoscopic or robot-assisted abdominal surgery
Key exclusion criteria (11 listed)
- Patients' refusal
- Change in operation schedule
- American Society of Anaesthesiologists (ASA) physical status Ⅳ
- Day surgery
- BMI ≥35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Giving orientation with headphonesDuring emergence, recorded voice of an investigator giving Information of orientation (time, place, patient's own name) is repeatedly played from noise-cancelling headphones | Other | Orientation |
| Emergence as usual with headphonesDuring emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones | Other | Name |
Primary outcome
Incidence of emergence agitation at operating room (OR)
Time frame: 20 minutes after anesthesia emergence
Riker sedation agitated scale ≥5
11 secondary outcomes
Incidence of dangerous emergence agitation
Time frame: 20 minutes after anesthesia emergence
maximal Riker sedation agitated scale during emergence
Time frame: 20 minutes after anesthesia emergence
Time to emergence
Time frame: 20 minutes after anesthesia emergence
Bispectral index (BIS)
Time frame: 20 minutes after anesthesia emergence
Incidence of emergence agitation at PACU
Time frame: 30 minutes after PACU adminstration
Incidence of postoperative delirium
Time frame: 30 minutes after PACU adminstration / Postoperative 24 hours
Postoperative Pain
Time frame: 10/20/30 minutes after PACU administation / Postoperative 24 hours
PACU stay
Time frame: up to 3 hours after PACU administration
Postoperative opioid consumption
Time frame: 30 minutes after PACU adminstration / Postoperative 24 hours
Analgesics requirement
Time frame: Postoperative 24 hours
Postoperative quality of recovery
Time frame: Postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 36697272Lee 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.
- Individual participant dataSharing planned: No
Related trials for Emergence Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Rim Kim, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giving orientation with headphones and Emergence as usual with headphones in people with Emergence Delirium, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence agitation at operating room (OR) (time frame: 20 minutes after anesthesia emergence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.