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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05105178
Other study ID # 21082521254
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2021
Est. completion date April 27, 2022

Study information

Verified date October 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date April 27, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 ? - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Giving 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
Emergence as usual with headphones
During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of emergence agitation at operating room (OR) Riker sedation agitated scale =5 20 minutes after anesthesia emergence
Secondary Incidence of dangerous emergence agitation Riker sedation agitated scale =7 20 minutes after anesthesia emergence
Secondary maximal Riker sedation agitated scale during emergence maximum value of Riker sedation agitated scale during emergence 20 minutes after anesthesia emergence
Secondary Time to emergence Time from anesthetics off to eye opening/extubation/discharge from OR 20 minutes after anesthesia emergence
Secondary Bispectral index (BIS) BIS value at desflurane discontinuation/verbal response/extubation 20 minutes after anesthesia emergence
Secondary Incidence of emergence agitation at PACU Riker sedation agitated scale =5 30 minutes after PACU adminstration
Secondary Incidence of postoperative delirium Delirium scale (CAM) 30 minutes after PACU adminstration / Postoperative 24 hours
Secondary Postoperative Pain NRS score (0-11) of pain 10/20/30 minutes after PACU administation / Postoperative 24 hours
Secondary PACU stay Length (hours) of PACU stay up to 3 hours after PACU administration
Secondary Postoperative opioid consumption Postoperative opioid requirement 30 minutes after PACU adminstration / Postoperative 24 hours
Secondary Analgesics requirement Analgesics other than opioid requirement Postoperative 24 hours
Secondary Postoperative quality of recovery Korean version of quality of recovery-15 Postoperative 24 hours
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