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NCT Number: NCT06392308

The Impact of Smoking on the Prognosis of 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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

None intervention

Other

No interventions are administered to either group of patients.

Primary outcomes

  1. Postoperative delirium

    Time frame: Within 3 days post-surgery

    CAM method

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao-Chao Zhong, M.D.;P.H.D

CONTACT

[email protected]

+8615152460489

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

The Impact of Smoking on Postoperative Delirium and Recovery Quality in Elderly Surgical Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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