The Impact of Smoking on the Prognosis of Elderly Surgical Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorAffiliated Hospital of Nantong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • none intervention

    Other intervention

    No interventions are administered to either group of patients.

Treatment groups

121 Participants
are divided into 2 treatment groups
Group A: Smoker group1 intervention
Group B: Non-smoker group1 intervention

Trial outcomes

Primary outcomes

1

Postoperative delirium

CAM method

Time frame
Within 3 days post-surgery
2

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.

Time frame
Up to 24 hours after surgery.

Secondary outcomes

Other outcomes

Sponsors and contacts

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