Emotional and orientation support to prevent delirium in elderly surgical patients
The Role of Emotional and Orientation Support in Prevention of Postoperative Delirium Among Elderly Surgical Patients - a Multiple-crossover Clinical Trial
This study is testing if giving emotional support and allowing patients to keep their hearing and visual aids can help prevent confusion after surgery in older adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 70 Years to 120 Years |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT05140993 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate whether providing emotional and orientation support can reduce the incidence of postoperative delirium in elderly patients undergoing elective non-cardiac surgery. The approach involves allowing patients to keep their hearing and visual aids and having a family member escort them into the operating room until anesthesia induction. The study will actively screen for delirium starting at the post-anesthesia care unit (PACU) admission and continue for at least two postoperative days. A multiple cross-over design will be used to alternate between the intervention and standard practice, which typically involves removing sensory aids and not allowing escorts beyond a certain point.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 70 years and older undergoing elective non-cardiac surgery.
Not a fit: Patients with known psychiatric or severe neurologic disorders, preoperative cognitive decline, or those unable to cooperate with delirium screening may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium, improving recovery outcomes for elderly surgical patients.
How similar studies have performed: While the specific approach of this study may be novel, other studies have indicated that interventions aimed at reducing risk factors for postoperative delirium can be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age ≥ 70 years 2. having non-cardiac and non-cranial surgery in the Tel-Aviv Medical Center Exclusion Criteria: 1. Known psychiatric or severe neurologic disorder (e.g., Alzheimer's disease, past stroke) 2. Preoperative cognitive decline (MiniCog test result \< 3 points) 3. Not planned to be extubated and awaken at surgery conclusion 4. Known inability to cooperate with postoperative delirium screening (language barrier, aphasia)
Where this trial is running
Tel Aviv
- Division of Anesthesiology, Intensive Care Medicine and Pain management, Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Barak Cohen, MD — Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel
- Study coordinator: Barak Cohen, MD
- Email: barakc@tlvmc.gov.il
- Phone: +97236974093
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.