NCT06973967

Brief Summary

The aim of this study is to investigate the relationship between low-flow and normal-flow anesthesia techniques and the development of postoperative delirium in elderly patients undergoing surgery for hip fracture.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

May 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 6, 2025

Last Update Submit

May 14, 2025

Conditions

Keywords

deliriumhip surgeryelderly patientslow-flow anesthesia

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative delirium is lower in patients receiving low-flow anesthesia compared to those receiving normal-flow anesthesia.

    7 days

Secondary Outcomes (3)

  • 28-day mortality

    28 days

  • Correlation Between NIRS Monitoring Values and Postoperative Delirium

    7 days

  • Correlation Between BIS Values and Postoperative Delirium

    First 7 postoperative days

Study Arms (1)

Patients over the age of 65 who undergo hip fracture surgery under general anesthesia

Patients over the age of 65 who undergo hip fracture surgery under general anesthesia

Behavioral: delirium

Interventions

deliriumBEHAVIORAL

Postoperatively, patients were monitored for delirium for seven days.

Patients over the age of 65 who undergo hip fracture surgery under general anesthesia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly Patients Undergoing Hip Fracture Surgery

You may qualify if:

  • Patients aged 65 years and older who are scheduled to undergo surgical treatment for hip fracture, classified as ASA physical status I-IV, and who have signed the informed consent form will be included in the study.

You may not qualify if:

  • Patients with complex fractures (multiple fractures, extremity, abdominal, pelvic or sacral trauma, head trauma, etc.), those with relative contraindications to general anesthesia (e.g., known difficult airway, malignant hyperthermia), patients requiring postoperative intubated intensive care follow-up, those with a history of dementia, sleep disorders, or psychosis, individuals with serious neurological diseases (e.g., Parkinson's disease, stroke sequelae), those with a history of opioid, alcohol, or substance use, patients with cerebrovascular disease, those who underwent surgery within the past 6 months, patients with hearing or vision impairment, bleeding disorders or those taking medications affecting coagulation, patients with hypoalbuminemia (\<3 g/dL), preoperative anemia with hematocrit \<30%, known allergy to anesthetic drugs, severe cardiopulmonary failure, immobility, malnutrition, or those who are unable to comply with the study protocol will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence DeliriumDelirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 15, 2025

Study Start

May 8, 2025

Primary Completion

July 31, 2025

Study Completion

August 7, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share