NCT05140993 The Role of Emotional and Orientation Support in Prevention of Postoperative Delirium Among Elderly Surgical Patients
| NCT ID | NCT05140993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barak Cohen, MD |
| Condition | Postoperative Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2022-06-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Postoperative delirium is common and associated with significant adverse outcomes. Its etiology is unknown, and little is known about associated risk factors. The investigatorea aim to test whether providing emotional and orientation support can reduce the risk of postoperative delirium in elderly patients undergoing elective non-cardiac surgery. Specifically, the investigators will test whether allowing such patients to keep their hearing and visual aids and be escorted into the operating room by a family member until anesthesia induction reduces the incidence of postoperative delirium. Delirium will be actively screened as part of our institution's clinical practice starting at PACU admission and for a minimum of 2 postoperative days. The investigators will use a multiple cross-over design to enroll all eligible patients and alternate between the intervention and our common practice (removing sensorial aids in the preoperative area and not allowing patients' escort beyond that point) every 2 weeks for up to 2 years.
Eligibility 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)
Contact & Investigator
Barak Cohen, MD
PRINCIPAL INVESTIGATOR
Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel
Frequently Asked Questions
Who can join the NCT05140993 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, up to 120 Years, studying Postoperative Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05140993 currently recruiting?
Yes, NCT05140993 is actively recruiting participants. Contact the research team at barakc@tlvmc.gov.il for enrollment information.
Where is the NCT05140993 trial being conducted?
This trial is being conducted at Tel Aviv, Israel.
Who is sponsoring the NCT05140993 clinical trial?
NCT05140993 is sponsored by Barak Cohen, MD. The principal investigator is Barak Cohen, MD at Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel. The trial plans to enroll 2,000 participants.