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

NCT05140993 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2024-11-20

No results posted yet for this study

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

Interventions

BEHAVIORAL

extended emotional and orientation support

extended emotional and orientation support

Sponsors & Collaborators

  • Barak Cohen, MD

    lead OTHER_GOV

Principal Investigators

  • Barak Cohen, MD · Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
70 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-11-01
Completion
2025-11-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05140993 on ClinicalTrials.gov