Delirium, PostoperativeNCT06392308
The Impact of Smoking on the Prognosis of Elderly Surgical Patients
An observational study of Delirium, Postoperative, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Postoperative delirium is a common complication that frequently occurs in elderly patients after surgery. It not only increases the length of hospital stays and healthcare costs but also raises the incidence of postoperative cognitive dysfunction and even mortality. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Delirium, Postoperative
- What is being tested?
- none intervention
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- Adult, Older adult
Study population: Elderly patients who meet the inclusion criteria are divided into a smoking group and a non-smoking group based on their smoking status. The general information of the patients, perioperative data, and postoperative follow-up data are recorded. By conducting propensity score matching analysis, differences in outcomes due to confounding factors are minimized, and exploratory analysis is performed on the matched patient data to investigate the impact of gut microbiota and metabolism on the incidence of postoperative delirium and the quality of postoperative recovery.
Who may be able to join
- Age >60 years;
- American Society of Anesthesiologists (ASA) preoperative anesthesia classification ASA Grades I and II;
- Undergoing elective surgery;
- Patients and their families are able to understand and complete various scoring scales and voluntarily sign informed consent.
Who cannot join
- Mini-Mental State Examination (MMSE) score <23;
- Preoperative biochemical tests indicate renal dysfunction or active liver disease;
- History of definite neurological or psychiatric disorders or history of taking corresponding medications before surgery;
- History of alcohol abuse or drug dependency;
- Taking antidepressant medications;
- American Society of Anesthesiologists (ASA) preoperative anesthesia classification > Grade II.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Smoking on Postoperative Delirium and Recovery Quality in Elderly Surgical Patients
Postoperative delirium is a common complication that frequently occurs in elderly patients after surgery. It not only increases the length of hospital stays and healthcare costs but also raises the incidence of postoperative cognitive dysfunction and even mortality. However, the underlying mechanisms of its onset are not yet fully understood. Evidence suggests that smoking can lead to gut microbiota dysbiosis and metabolic dysfunction, and the gut microbiota and its metabolites play a crucial role in cognitive function through the gut-brain axis. Yet, no studies have reported whether smoking could affect the occurrence of postoperative delirium and the quality of postoperative recovery through the gut microbiota. This study aims to observe the incidence of postoperative delirium and the postoperative recovery quality scores between smokers and non-smokers.
Read the detailed description
After obtaining approval from the ethics committee, patients are recruited, informed of the trial process and potential risks, and their informed consent is obtained and signed. According to the WHO definition, patients are classified into smokers (defined as those who smoke more than one cigarette per day continuously or cumulatively for six months; more than four times a week but averaging less than one cigarette per day) and non-smokers (never smoked). Fecal and blood samples are collected from both groups of patients preoperatively, and perioperative data is gathered. Postoperatively, an uninformed observer assesses the patients for delirium and recovery quality.
- Conditions
- Delirium, Postoperative
- Being tested
- none intervention
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
No interventions are administered to either group of patients.
| Study group | Role | What they receive |
|---|---|---|
| Smoker group | who smoke more than one cigarette per day continuously or cumulatively for six months; more than four times a week but averaging less than one cigarette per day Receives: Other: none intervention | |
| Non-smoker group | never smoke Receives: Other: none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
CAM method
Measured: Within 3 days post-surgery
Quality of recovery in the first postoperative day
Quality of recovery is assessed with the Quality of Recovery-15 questionaire in the first postoperative day.
Measured: Up to 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaochao Zhong, Affiliated Hospital of Nantong University
- Investigators
- Chao-Chao Zhong, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392308
- Sponsor's protocol ID
- 2023-K213-01
- Status last verified
- Jan 2025
- First submitted
- 26 Apr 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Smoking on Postoperative Delirium and Recovery Quality in Elderly Surgical Patients
- ClinicalTrials.gov ID
- NCT06392308
- Acronym / sponsor ID
- 2023-K213-01
- Conditions
- Delirium, Postoperative
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
Postoperative delirium is a common complication that frequently occurs in elderly patients after surgery. It not only increases the length of hospital stays and healthcare costs but also raises the incidence of postoperative cognitive dysfunction and even mortality. However, the underlying mechanisms of its onset are not yet fully understood. Evidence suggests that smoking can lead to gut microbiota dysbiosis and metabolic dysfunction, and the gut microbiota and its metabolites play a crucial role in cognitive function through the gut-brain axis. Yet, no studies have reported whether smoking could affect the occurrence of postoperative delirium and the quality of postoperative recovery through the gut microbiota. This study aims to observe the incidence of postoperative delirium and the postoperative recovery quality scores between smokers and non-smokers.
Detailed description
After obtaining approval from the ethics committee, patients are recruited, informed of the trial process and potential risks, and their informed consent is obtained and signed. According to the WHO definition, patients are classified into smokers (defined as those who smoke more than one cigarette per day continuously or cumulatively for six months; more than four times a week but averaging less than one cigarette per day) and non-smokers (never smoked). Fecal and blood samples are collected from both groups of patients preoperatively, and perioperative data is gathered. Postoperatively, an uninformed observer assesses the patients for delirium and recovery quality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoker group | – | Other: none interventionwho smoke more than one cigarette per day continuously or cumulatively for six months; more than four times a week but averaging less than one cigarette per day |
| Non-smoker group | – | Other: none interventionnever smoke |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Elderly patients who meet the inclusion criteria are divided into a smoking group and a non-smoking group based on their smoking status. The general information of the patients, perioperative data, and postoperative follow-up data are recorded. By conducting propensity score matching analysis, differences in outcomes due to confounding factors are minimized, and exploratory analysis is performed on the matched patient data to investigate the impact of gut microbiota and metabolism on the incidence of postoperative delirium and the quality of postoperative recovery.
Key inclusion criteria (4 listed)
- Age >60 years;
- American Society of Anesthesiologists (ASA) preoperative anesthesia classification ASA Grades I and II;
- Undergoing elective surgery;
- Patients and their families are able to understand and complete various scoring scales and voluntarily sign informed consent.
Key exclusion criteria (6 listed)
- Mini-Mental State Examination (MMSE) score <23;
- Preoperative biochemical tests indicate renal dysfunction or active liver disease;
- History of definite neurological or psychiatric disorders or history of taking corresponding medications before surgery;
- History of alcohol abuse or drug dependency;
- Taking antidepressant medications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none interventionNo interventions are administered to either group of patients. | Other | Non-smoker group, Smoker group |
Primary outcome
Postoperative delirium
Time frame: Within 3 days post-surgery
CAM method
Quality of recovery in the first postoperative day
Time frame: Up to 24 hours after surgery.
Quality of recovery is assessed with the Quality of Recovery-15 questionaire in the first postoperative day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Chao-Chao Zhong principal investigator
Affiliated Hospital of Nantong 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 Delirium, Postoperative, run by Affiliated Hospital of Nantong 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 6 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: opening soon, as of the sponsor's last update on 16 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao-Chao Zhong, M.D.;P.H.D (+8615152460489, zhong249767626@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: Within 3 days post-surgery). The study lists 2 primary outcomes in all. 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 16 Jan 2025.