The Impact of Repetitive Transcranial Magnetic Stimulation on the Prognosis of Elderly Surgical Patients

Postoperative Delirium Clinical Trial

Official title:

Effects of Perioperative Repetitive Transcranial Magnetic Stimulation on Postoperative Delirium, Postoperative Cognitive Dysfunction, and Chronic Post-surgical Pain in Elderly Surgical Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06392919
• Other study ID #: 2024-K005-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Affiliated Hospital of Nantong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exploring the effects of repeated transcranial magnetic stimulation (rTMS) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms.

Description:

Patients are recruited one week prior to the trial commencement, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants.Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham rTMS group) and the intervention group (rTMS group, with rTMS intervention applied in the PACU after surgery) in a double-blind manner (with rTMS intervention and postoperative follow-up conducted by different researchers).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age = 60 years;

• ASA = 3;

• Elective surgery patients.

Exclusion Criteria:

• Refusal to sign the consent form;

• Mini-Mental State Examination (MMSE) score < 15;

• Preoperative neuropsychiatric diseases and history of neurological or psychiatric disorders;

• Preoperative cranial or scalp injuries;

• History of drug or alcohol abuse; Visual or auditory impairments, communication difficulties; Presence of metallic implants in the body; Preoperative history of severe cardiovascular disease or severe liver or kidney dysfunction.

Related Conditions & MeSH terms

• Chronic Post-surgical Pain
• Cognitive Dysfunction
• Delirium
• Emergence Delirium
• Pain, Postoperative
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
rTMS intervention timing: rTMS is applied after the tracheal tube is removed in the PACU. Stimulation site: DLPFC (left dorsolateral prefrontal cortex); Stimulation intensity: 100% RMT; Stimulation frequency: 10Hz; Total number of stimulation pulses: 2000. Pulse characteristics: Each duration lasts 5 seconds, with a 25-second interval.

Locations

Country	Name	City	State
China	Affiliated hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium during the first 3 days after surgery	Delirium is assessed twice daily (8-10 AM and 6-8 PM) with the Confusion Assessment Method for patients without endotracheal intubation during the first 3 days after surgery.	The first 3 days after surgery
Primary	Incidence of Postoperative Cognitive Dysfunction	Cognitive function assessed with MoCA (Montreal Cognitive Assessment) test on the 30th day after surgery	1 month after surgery
Primary	Incidence of chronic postsurgical pain (CPSP) at 3 months after surgery	CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection). Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain, both at rest and with movement.	At 3 months after surgery