Using dexmedetomidine to reduce postoperative delirium in elderly patients after major abdominal surgery
Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: a Randomized Controlled Study
This study is testing if giving dexmedetomidine during major abdominal surgery can help prevent confusion and delirium in elderly patients after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 3 sites (Beijing and 2 other locations) |
| Trial ID | NCT05436964 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium in elderly patients undergoing major abdominal surgery. Three hundred patients over 65 years old will be randomized into two groups: one receiving dexmedetomidine and the other receiving saline as a placebo. The intervention involves a loading dose followed by a continuous infusion during surgery, with follow-up assessments conducted at 1-5 days and 1 month post-surgery to measure delirium incidence, analgesic requirements, and pain scores.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older who are scheduled for elective major abdominal surgery.
Not a fit: Patients with severe preoperative cognitive impairment or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium in elderly patients, improving their recovery and overall outcomes.
How similar studies have performed: Previous studies have shown promising results with dexmedetomidine in reducing postoperative complications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 65 years old * Patients undergoing elective major abdominal surgery * Written informed consent was obtained Exclusion Criteria: * Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation. * Patients with history of psychiatric or neurological disorders. * Patients with body mass index ≤ 18 or ≥ 30 * Patients with severe bradycardia (heart rate less than 40 beats per minute) * Patients with pathological sinus node syndrome or grade 2 or greater AV block * Patients with severe hepatic or renal insufficiency. * Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
Where this trial is running
Beijing and 2 other locations
- Beijing Tiantan Hospital,Capital Medical University — Beijing, China (Recruiting)
- Chinese PLA General Hospital — Beijing, China (Recruiting)
- Central theater General Hospital — Wuhan, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Hao Li — Chinese PLA General Hospital
- Study coordinator: Hao Li
- Email: lihao301@126.com
- Phone: 15010665099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.