Verbal Stimulation of Orientation on Emergence Agitation

Seoul National University

Status: Completed

Conditions: Emergence Delirium

Treatments: Other: Emergence as usual with headphones; Other: Giving orientation with headphones

Study type: Interventional

Funder types: Other

Identifiers

NCT05105178

21082521254

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Orientation

Experimental group

Description:

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

Treatment:

Other: Giving orientation with headphones

Name

Active Comparator group

Description:

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

Treatment:

Other: Emergence as usual with headphones