Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070, China
Location status: Recruiting
Location contact
Ruquan Han, M.D., Ph.D
CONTACT
Ruquan Han, M.D., Ph.D
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06421077
According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Beijing, 100070, China
Location status: Recruiting
Ruquan Han, M.D., Ph.D
CONTACT
Ruquan Han, M.D., Ph.D
PRINCIPAL_INVESTIGATOR
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS(25HZ,250μs), while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
transauricular auricular vagus nerve stimulation
Time frame: At discharge or within 5 days postoperatively
POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge
Time frame: Day 1 before surgery, day 5 after surgery, day 90 after surgery
The MMSE/MoCA scale were used for evaluation
Time frame: on the 90 days
assessed by AMTS scale
Time frame: on the 90 days
use the IADL score
Time frame: on the 90 days
Time frame: on the 90 days
Time frame: on the 90 days
Time frame: on the 90 days
Time frame: At discharge or within 5 days postoperatively
Delirium severity was assessed via the 3D-CAM-S scale. 3D-CAM-S scale: The total score is 7, with 0 being normal, 1 being mild delirium, 2 being moderate delirium, and 3-7 being severe delirium
Contact information is provided by the study sponsor or research team.
Beijing Tiantan Hospital
Other
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
Acronym: Vnstar
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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