Postoperative DeliriumNCT05551026
Effects of Perioperative Operating Room Environment on Postoperative Delirium
An observational study of Postoperative Delirium, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Delirium
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2022to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients who underwent abdominal surgery under general anesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
He Huang, M.D., (+86)13708385559, huanghe@cqmu.edu.cn
About this study
Official title: Effects of Perioperative Operating Room Environment on Postoperative Delirium in Elderly Patients With Abdominal Surgery : A Prospective Cohort Study
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
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ending of the surgery to 3 days after anesthetic resuscitation
Secondary outcomes (3)
Postoperative delirium in the postanesthesia care unit
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.
Measured: From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes
Hospital stay
Time duration of the patients' stay in hospital
Measured: From the ending of the surgery to hospital discharge, with means of about 7 days
Postoperative complication
The number of patients who having complication during the hospitalization
Measured: From the ending of the surgery to hospital discharge, with means of about 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start22 Aug 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion26 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Tang, MD, Study director, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551026
- Sponsor's protocol ID
- Factors of POD
- Status last verified
- Dec 2022
- First submitted
- 20 Sep 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Operating Room Environment on Postoperative Delirium in Elderly Patients With Abdominal Surgery : A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05551026
- Acronym / sponsor ID
- Factors of POD
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 26 Feb 2024 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients who underwent abdominal surgery under general anesthesia.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative delirium during the 3 days-follow-up after anesthetic resuscitation
Time frame: 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.
3 secondary outcomes
Postoperative delirium in the postanesthesia care unit
Time frame: From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes
Hospital stay
Time frame: From the ending of the surgery to hospital discharge, with means of about 7 days
Postoperative complication
Time frame: From the ending of the surgery to hospital discharge, with means of about 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Tang, MD study director
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang He, MD (（+86）13708385559, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium during the 3 days-follow-up after anesthetic resuscitation (time frame: From ending of the surgery to 3 days after anesthetic resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.