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Verbal Stimulation of Orientation on Emergence Agitation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05105178
Enrollment
126
Registered
2021-11-03
Start date
2021-11-09
Completion date
2022-04-27
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Keywords

Emergence delirium, Emergence agitation, Orientation

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.

Interventions

OTHERGiving 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

OTHEREmergence as usual with headphones

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of emergence agitation at operating room (OR)20 minutes after anesthesia emergenceRiker sedation agitated scale ≥5

Secondary

MeasureTime frameDescription
maximal Riker sedation agitated scale during emergence20 minutes after anesthesia emergencemaximum value of Riker sedation agitated scale during emergence
Time to emergence20 minutes after anesthesia emergenceTime from anesthetics off to eye opening/extubation/discharge from OR
Incidence of dangerous emergence agitation20 minutes after anesthesia emergenceRiker sedation agitated scale =7
Bispectral index (BIS)20 minutes after anesthesia emergenceBIS value at desflurane discontinuation/verbal response/extubation
Incidence of emergence agitation at PACU30 minutes after PACU adminstrationRiker sedation agitated scale ≥5
Incidence of postoperative delirium30 minutes after PACU adminstration / Postoperative 24 hoursDelirium scale (CAM)
Postoperative Pain10/20/30 minutes after PACU administation / Postoperative 24 hoursNRS score (0-11) of pain
PACU stayup to 3 hours after PACU administrationLength (hours) of PACU stay
Postoperative opioid consumption30 minutes after PACU adminstration / Postoperative 24 hoursPostoperative opioid requirement
Analgesics requirementPostoperative 24 hoursAnalgesics other than opioid requirement
Postoperative quality of recoveryPostoperative 24 hoursKorean version of quality of recovery-15

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026