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Not yet recruiting NCT07391631

Preoperative and Postoperative Fasting and Delirium

Observational Postoperative Delirium Perioperative Fasting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Postoperative Delirium Perioperative Fasting. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Relationship Between Preoperative and Postoperative Fasting Durations and Postoperative Delirium

Overview

Postoperative delirium is a common and serious complication after surgery, especially in older patients, and is associated with prolonged hospital stay and worse recovery. Fasting before and after surgery is a routine part of perioperative care; however, prolonged fasting may negatively affect recovery and brain function. This prospective, observational, multicenter study aims to evaluate the relationship between preoperative and postoperative fasting durations and the development of postoperative delirium in adult patients undergoing elective or emergency surgery under general or regional anesthesia. Fasting times before and after surgery will be recorded. Patients will be assessed for postoperative delirium during the first three postoperative days using validated screening tools. No additional interventions will be applied, and all patients will receive standard perioperative care. The results of this study may help identify whether prolonged fasting is associated with a higher risk of postoperative delirium and may contribute to improving perioperative fasting practices and patient safety.

Detailed description

This is a prospective, observational, multicenter study designed to investigate the association between preoperative and postoperative fasting durations and the occurrence of postoperative delirium in adult surgical patients.

Adult patients (≥18 years) undergoing elective or emergency surgery under general or regional anesthesia will be included. Patients with pre-existing delirium, advanced dementia, postoperative intensive care unit admission, or inability to complete delirium assessments will be excluded.

Preoperative fasting duration will be defined as the time from the last oral intake to the induction of anesthesia. Postoperative fasting duration will be defined as the time from the end of surgery to the first oral intake. Fasting durations will be recorded for each participant.

Postoperative delirium will be assessed using validated screening tools (Confusion Assessment Method or Nursing Delirium Screening Scale) twice daily during the first three postoperative days. Routine perioperative management will not be altered for study purposes, and no study-specific interventions will be applied.

Demographic data, comorbidities, type of surgery, and perioperative clinical parameters will be collected as part of standard care. The primary objective is to evaluate the relationship between fasting durations and postoperative delirium. Secondary analyses will explore factors associated with delirium development.

Primary outcome measures

  • Incidence of postoperative delirium [Time frame: During the first 3 postoperative days]
Secondary outcome measures (1)
  • Duration of postoperative delirium [Time frame: During the first 3 postoperative days]

Eligibility criteria

Inclusion Criteria:Adults aged 18 years or older

Patients undergoing elective or emergency surgery under general or regional anesthesia

Ability to communicate and cooperate with postoperative delirium assessments

Expected postoperative hospital stay of at least 72 hours

Provision of written informed consent

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Exclusion Criteria:Presence of preoperative delirium (positive CAM or Nu-DESC ≥2)

Advanced dementia or severe cognitive impairment

Planned postoperative intensive care unit admission

Active alcohol or benzodiazepine withdrawal

Inability to complete delirium assessments due to severe hearing, vision, or speech impairment

Lack of postoperative follow-up availability

Planned cardiac surgery

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07391631 · TARD_FASTING_POD_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗