Effects of Perioperative Operating Room Environment on Postoperative Delirium

NCT05551026 | Unknown DMC

• 1 other identifier: Factors of POD
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Thi investigators aims to observe the impact of perioperative body temperature and the noise of operating room on postoperative delirium for elderly patients undergoing abdominal surgery. And based on this study the investigators aimed to explore the potential risk factors of postoperative delirium for elderly patients undergoing abdominal surgery.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium during the 3 days-follow-up after anesthetic resuscitation

  Postoperative delirium was tested with 3 minutes-Confusion Assessment Method or Confusion Assessment Method-intensive care unit (0-4, higher scores means worse outcome). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.

  From ending of the surgery to 3 days after anesthetic resuscitation

Secondary Outcomes (3)

• Postoperative delirium in the postanesthesia care unit

  From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes

• Hospital stay

  From the ending of the surgery to hospital discharge, with means of about 7 days

• Postoperative complication

  From the ending of the surgery to hospital discharge, with means of about 7 days

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients who underwent abdominal surgery under general anesthesia.

You may qualify if:

• Age 65-90 years old;
• ASA I-III;
• Patients who plan to undergo elective abdominal surgery under general anesthesia;
• Volunteer to participate in this study and sign informed consent.

You may not qualify if:

• Patients with known mental illness or lack of communication or cognitive impairment before operation;
• Severe vision, hearing, language impairment or other reasons unable to communicate with visitors;
• Severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.;
• Long-term use of sedatives, antidepressants or alcoholism;
• Patients with severe postoperative complications and admitted to intensive care unit;
• Patients who refused or failed to complete the cognitive function test.
• Patients who could not cooperate with the study for any other reason.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

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

• Jia Tang, MD

  Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Huang He, MD

CONTACT

（+86）13708385559; huanghe@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: August 22, 2022
• Primary Completion: December 30, 2023
• Study Completion: February 26, 2024
• Last Updated: October 23, 2023

Record last verified: 2022-12

Locations

CN (1)