Delirium - PostoperativeNCT06973967
Low- vs. Normal-Flow Anesthesia and Delirium After Hip Fracture in the Elderly
An observational study of Delirium - Postoperative and Low Flow Anesthesia, run by Gaziosmanpasa Research and Education Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium - Postoperative, Low Flow Anesthesia, Elderly Patients (>65 Years)
- What is being tested?
- delirium
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2025to 7 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly Patients Undergoing Hip Fracture Surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Association Between Low-Flow and Normal-Flow Anesthesia and Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
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.
Read the detailed description
Materials and Methods:
Study Design and Ethical Approval:
This study is designed as a prospective observational study. Ethical approval has been obtained, and the study will be conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent will be obtained from all patients enrolled in the study.
There will be no intervention or randomization by the investigators in the selection of patients; the choice between low-flow and normal-flow anesthesia will be left to the discretion of the attending anesthesiologist as per routine clinical practice. Patients aged ≥65 years who are admitted to SBÜ Gaziosmanpaşa Training and Research Hospital due to hip fracture and are scheduled for surgery will be included in the study.
This is a single-center study. Postoperative outcomes including the incidence and duration of delirium on postoperative days 1, 3, and 7, visual pain and sedation scores, length of hospital stay, and associated complications will be evaluated. Postoperative sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS), and pain will be assessed using the Visual Analog Scale (VAS), both of which are part of routine hospital practice. In addition, the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be used to evaluate the presence of delirium in study participants.
The study is planned to continue for a duration of six (6) months.
Study Population:
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Data Collection:
Demographic data of the patients (age, gender, body mass index, and comorbidities) as well as their preoperative cognitive status will be recorded. During the perioperative period, data including vital parameters, medications used, duration of anesthesia, amount of blood loss, and fluid balance will be collected.
Postoperative Assessment:
Postoperative delirium will be assessed on postoperative days 1, 3, and 7 using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), the Visual Analog Scale (VAS), and the Richmond Agitation-Sedation Scale (RASS). In addition, intensive care unit (ICU) requirement, length of hospital stay, and mortality rates of the patients will be recorded.
Statistical Methods to Be Used:
- The data will be analyzed using SPSS version 25.0 (IBM Company).
Analysis of Demographic and Clinical Data:
- Frequency and percentage distributions will be calculated for categorical variables such as patients' demographic characteristics, smoking and alcohol use, type and amount of analgesics, use of blood products, amount of bleeding, presence of chronic diseases, height, weight, body mass index (BMI), duration of surgery, length of hospital stay, and anesthesia techniques.
- To examine the relationships between categorical variables, the Chi-square test or Fisher's exact test will be used as appropriate. The independent samples t-test will be applied where necessary. Correlation or regression analysis will be used to examine the relationships between numerical variables. The statistical significance of differences will be evaluated using the Log-rank test.
Optimization Techniques (Minitab):
- If needed, optimization techniques such as Response Surface Methodology (RSM) may be applied using the Minitab statistical software.
- Conditions
- Delirium - Postoperative, Low Flow Anesthesia, Elderly Patients (>65 Years), Hip Surgery
- Being tested
- delirium
- Keywords
- delirium, hip surgery, elderly patients, low-flow anesthesia
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deliriumBehavioural
Postoperatively, patients were monitored for delirium for seven days.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: delirium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium is lower in patients receiving low-flow anesthesia compared to those receiving normal-flow anesthesia.
Measured: 7 days
Secondary outcomes (3)
28-day mortality
Measured: 28 days
Correlation Between NIRS Monitoring Values and Postoperative Delirium
Postoperative delirium will be assessed using the Confusion Assessment Method for the ICU (CAM-ICU). NIRS will be recorded intraoperatively as mean regional cerebral oxygen saturation (%). Correlation between mean NIRS values and the incidence of postoperative delirium will be analyzed.
Measured: 7 days
Correlation Between BIS Values and Postoperative Delirium
BIS values (mean intraoperative BIS score) will be recorded and correlated with postoperative delirium status measured by CAM-ICU.
Measured: First 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start8 May 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion7 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, veysel Dinç, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973967
- Sponsor's protocol ID
- GaziosmanpasaTREH, VD
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Low-Flow and Normal-Flow Anesthesia and Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT06973967
- Acronym / sponsor ID
- GaziosmanpasaTREH, VD
- Conditions
- Delirium - Postoperative, Low Flow Anesthesia, Elderly Patients (>65 Years), Hip Surgery
- Keywords
- delirium, hip surgery, elderly patients, low-flow anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 8 May 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 7 Aug 2025 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Materials and Methods:
Study Design and Ethical Approval:
This study is designed as a prospective observational study. Ethical approval has been obtained, and the study will be conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent will be obtained from all patients enrolled in the study.
There will be no intervention or randomization by the investigators in the selection of patients; the choice between low-flow and normal-flow anesthesia will be left to the discretion of the attending anesthesiologist as per routine clinical practice. Patients aged ≥65 years who are admitted to SBÜ Gaziosmanpaşa Training and Research Hospital due to hip fracture and are scheduled for surgery will be included in the study.
This is a single-center study. Postoperative outcomes including the incidence and duration of delirium on postoperative days 1, 3, and 7, visual pain and sedation scores, length of hospital stay, and associated complications will be evaluated. Postoperative sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS), and pain will be assessed using the Visual Analog Scale (VAS), both of which are part of routine hospital practice. In addition, the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be used to evaluate the presence of delirium in study participants.
The study is planned to continue for a duration of six (6) months.
Study Population:
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Data Collection:
Demographic data of the patients (age, gender, body mass index, and comorbidities) as well as their preoperative cognitive status will be recorded. During the perioperative period, data including vital parameters, medications used, duration of anesthesia, amount of blood loss, and fluid balance will be collected.
Postoperative Assessment:
Postoperative delirium will be assessed on postoperative days 1, 3, and 7 using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), the Visual Analog Scale (VAS), and the Richmond Agitation-Sedation Scale (RASS). In addition, intensive care unit (ICU) requirement, length of hospital stay, and mortality rates of the patients will be recorded.
Statistical Methods to Be Used:
- The data will be analyzed using SPSS version 25.0 (IBM Company).
Analysis of Demographic and Clinical Data:
- Frequency and percentage distributions will be calculated for categorical variables such as patients' demographic characteristics, smoking and alcohol use, type and amount of analgesics, use of blood products, amount of bleeding, presence of chronic diseases, height, weight, body mass index (BMI), duration of surgery, length of hospital stay, and anesthesia techniques.
- To examine the relationships between categorical variables, the Chi-square test or Fisher's exact test will be used as appropriate. The independent samples t-test will be applied where necessary. Correlation or regression analysis will be used to examine the relationships between numerical variables. The statistical significance of differences will be evaluated using the Log-rank test.
Optimization Techniques (Minitab):
- If needed, optimization techniques such as Response Surface Methodology (RSM) may be applied using the Minitab statistical software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients over the age of 65 who undergo hip fracture surgery under general anesthesia | – | Behavioral: deliriumPatients over the age of 65 who undergo hip fracture surgery under general anesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly Patients Undergoing Hip Fracture Surgery
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deliriumPostoperatively, patients were monitored for delirium for seven days. | Behavioural | Patients over the age of 65 who undergo hip fracture surgery under general anesthesia |
Primary outcome
The incidence of postoperative delirium is lower in patients receiving low-flow anesthesia compared to those receiving normal-flow anesthesia.
Time frame: 7 days
3 secondary outcomes
28-day mortality
Time frame: 28 days
Correlation Between NIRS Monitoring Values and Postoperative Delirium
Time frame: 7 days
Correlation Between BIS Values and Postoperative Delirium
Time frame: First 7 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative and Low Flow Anesthesia, run by Gaziosmanpasa Research and Education Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veysel Dinç (+90 545 745 3472, drvdinc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium is lower in patients receiving low-flow anesthesia compared to those receiving normal-flow anesthesia. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.