Effects of Perioperative Operating Room Environment on Postoperative Delirium

Recruiting

• Conditions: Postoperative Delirium

• Registration Number: NCT05551026
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-22
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Status Verified: 2022-12
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-12-30
• Study Completion: 2024-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative delirium during the 3 days-follow-up after anesthetic resuscitation	From ending of the surgery to 3 days 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.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	From the ending of the surgery to hospital discharge, with means of about 7 days	Time duration of the patients' stay in hospital
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	Postoperative delirium was tested with 3 minutes-Confusion Assessment Method (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.
Postoperative complication	From the ending of the surgery to hospital discharge, with means of about 7 days	The number of patients who having complication during the hospitalization

Trial Locations

Locations (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China