- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07391631
Preoperative and Postoperative Fasting and Delirium (FAST-POD)
The Relationship Between Preoperative and Postoperative Fasting Durations and Postoperative Delirium
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: emel gündüz, md
- Phone Number: +902422496000
- Email: dregunduz@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative delirium
Time Frame: During the first 3 postoperative days
|
Postoperative delirium will be assessed using validated screening tools (Confusion Assessment Method or Nursing Delirium Screening Scale) during the first three postoperative days.
|
During the first 3 postoperative days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of postoperative delirium
Time Frame: During the first 3 postoperative days
|
The duration of postoperative delirium will be recorded based on daily delirium assessments during the first three postoperative days.
|
During the first 3 postoperative days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TARD_FASTING_POD_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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