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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06421051
Other study ID # HX-B-2024016
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 10, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Beijing Tiantan Hospital
Contact Ruquan Han, MD
Phone 8610-59976660
Email ruquan.han@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 164
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients undergoing non-craniocerebral surgery under elective general anesthesia - Age =65 years old - American society of Aneshesiologists Grade I to III - Sign informed consent Exclusion Criteria: - Patients who are expected to retain tracheal intubation after surgery - Disturbance of consciousness, mental disorder, inability to cooperate - Expected survival < 3 months - The estimated operation time is < 2 hours - The expected postoperative hospital stay is < 5 days

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transauricular Vagal Nerve Stimulation
Transauricular vagal nerve stimulation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of sleep disorders within 5 days after surgery. Day 1 to day 5 after surgery.
Secondary Sleep quality after surgery. The investigators collected patient-related information on postoperative days 1, 3, and 5 by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21, with higher scores indicating poorer sleep quality) and a sleep monitoring bracelet, and analyzed the subsequent data. Day 1,3,5 after surgery.
Secondary Postoperative pain score The investigators collected information from the patients on the 1st and 2nd postoperative days by Visual Analogue Scale and analyzed the data subsequently. The scale is based on a 10-cm horizontal line drawn on a piece of paper, with 0 cm at one end of the line indicating "no pain at all" and 10 cm at the other end indicating "extreme pain"; the level of pain increases from 0 to 10 cm, with higher scores indicating more intense pain. The higher the score, the more severe the pain. Day1 and 2 after surgery.
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