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Completed

NCT Number: NCT05105178

Verbal Stimulation of Orientation on Emergence Agitation

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.

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Key information

Conditions

Emergence Delirium Behavior Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Orientation, Spatial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spatial Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Giving orientation with headphones

Other

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 headphones

Other

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

Primary outcomes

  1. Incidence of emergence agitation at operating room (OR)

    Time frame: 20 minutes after anesthesia emergence

    Riker sedation agitated scale ≥5

Secondary outcomes

  1. Incidence of dangerous emergence agitation

    Time frame: 20 minutes after anesthesia emergence

    Riker sedation agitated scale =7

  2. maximal Riker sedation agitated scale during emergence

    Time frame: 20 minutes after anesthesia emergence

    maximum value of Riker sedation agitated scale during emergence

  3. Time to emergence

    Time frame: 20 minutes after anesthesia emergence

    Time from anesthetics off to eye opening/extubation/discharge from OR

  4. Bispectral index (BIS)

    Time frame: 20 minutes after anesthesia emergence

    BIS value at desflurane discontinuation/verbal response/extubation

  5. Incidence of emergence agitation at PACU

    Time frame: 30 minutes after PACU adminstration

    Riker sedation agitated scale ≥5

  6. Incidence of postoperative delirium

    Time frame: 30 minutes after PACU adminstration / Postoperative 24 hours

    Delirium scale (CAM)

  7. Postoperative Pain

    Time frame: 10/20/30 minutes after PACU administation / Postoperative 24 hours

    NRS score (0-11) of pain

  8. PACU stay

    Time frame: up to 3 hours after PACU administration

    Length (hours) of PACU stay

  9. Postoperative opioid consumption

    Time frame: 30 minutes after PACU adminstration / Postoperative 24 hours

    Postoperative opioid requirement

  10. Analgesics requirement

    Time frame: Postoperative 24 hours

    Analgesics other than opioid requirement

  11. Postoperative quality of recovery

    Time frame: Postoperative 24 hours

    Korean version of quality of recovery-15

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2021
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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