The Role of Emotional and Orientation Support in Prevention of Postoperative Delirium Among Elderly Surgical Patients

NCT05140993 | Recruiting

• 1 other identifier: 0483-21
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  A composite outcome of postoperative delirium, consisting of at least of the following - a positive 4A's test, positive 3D-CAM test, or delirium symptoms described in the nursing notes.

  Up to 30 postoperative days

Study Arms (2)

extended support

EXPERIMENTAL

providing extended emotional and orientation support

Behavioral: extended emotional and orientation support

common practice

NO INTERVENTION

The hospital routine clinical standard- not providing extended emotional and orientation support

Interventions

extended emotional and orientation support BEHAVIORAL

extended emotional and orientation support

extended support

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥ 70 years
• having non-cardiac and non-cranial surgery in the Tel-Aviv Medical Center

You may not qualify if:

• Known psychiatric or severe neurologic disorder (e.g., Alzheimer's disease, past stroke)
• Preoperative cognitive decline (MiniCog test result \< 3 points)
• Not planned to be extubated and awaken at surgery conclusion
• Known inability to cooperate with postoperative delirium screening (language barrier, aphasia)

Sponsors & Collaborators

• Barak Cohen, MD: lead

Study Sites (1)

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

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Barak Cohen, MD

  Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barak Cohen, MD

CONTACT

+97236974093; barakc@tlvmc.gov.il

Yuval Baar, MSc

CONTACT

+97236974093; yuvalba@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair Division of Anesthesiology, Intensive Care Medicine and Pain management, Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel

Model Details: suggest a single-center, open-label, multiple-crossover trial in which all eligible patients will be enrolled, and the intervention (providing extended emotional and orientation support) will be altered every two weeks against the control, which is the current clinical practice.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: December 2, 2021
• Study Start: June 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

IL (1)