PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUMNCT06273358
Preoperative Sleep Quality and Postoperative Delirium
An observational study of PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 27 Jan 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the sample size analysis, it was determined that there should be 72 patients for each group with an alpha margin of error of 0.05, with a power rate of 80% for comparison of two groups. The effect used for this calculation was calculated as 0.417, and the actual power was calculated as 0.801, based on similar studies. As a result of the analysis, considering the drop out rate, it was planned to include 75 patients for each group.
Who may be able to join
- Patients will be eligible if:
- Patients receiving general anesthesia
- Elective noncardiac surgery lasting more than 2 hours
- Patients in the ASA2-3 risk group
- Patients aged >45 years
Who cannot join
- Patients will not be eligible if:
- Septic table (clinically diagnosed by the relevant anesthesiologist)
- Inadequate recording of delirium assessment;
- Previous history of post-surgical delirium
- Current or previously diagnosed neurocognitive disease.
- Patients who are foreigners or have difficulty communicating due to communication problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Sleep Quality on Postoperative Delirium Status in Adult Patients
Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.
Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years [SD]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean.
Read the detailed description
The global old population has grown as life quality has improved. According to WHO and UN publications, people 65 and older are mostly examined, and 60 and older are examined. The Turkish Statistical Institute (TUIK) reports 8 million,245 thousand 124 senior people in Turkey as of December 31, 2022. In December 2021, 9.7% of the population was 65 or older.
In 2021, 9.56% of the global population was 65 or older. Countries' aging processes vary. In 2021, 28.7% of Japan's population was elderly, while the United Arab Emirates had 1.4%. The rate of elderly patients over 65 obtaining general anesthesia for surgery has also grown. Noncardiac surgery often causes delirium in 10-40% of patients. Delirium increases the likelihood of postoperative mortality and poor neurocognitive recovery. The patient, family, and healthcare system are affected by postoperative delirium.
Delirium is difficult to avoid and cure because to its unknown pathophysiology. Evidence suggests that age, frailty, comorbidities, and substance addiction are predisposing and triggering factors. Other risk factors for delirium include perioperative opioid and benzodiazepine usage, operation severity and type, extreme pain, neuroinflammation, and electrolyte problems. Delirium in critically ill individuals is characterized by organ malfunction, acute-onset cognitive impairment, visual hallucinations, delusions, and illusions.
Initial cognitive impairment, acute sickness, dehydration, and aging enhance hospitalized patient delirium. Male gender, alcohol addiction, fractures, depression, visual impairments, and dementia predispose to delirium; restraint, nutritional disorders, multiple medications, urinary catheter, infections, too much or too little sensory stimulation (social isolation), noise, pain, neuroleptics or narcotics, frequent hospital room changes, no clock, no glasses, Surgery, medical procedures, and intensive care can cause delirium (2,16-18).
Critically sick individuals have poor sleep quality and quantity. Sleep disturbances can have a substantial personal and socioeconomic impact on people with respiratory, cardiovascular, metabolic, and mental diseases. In critically ill individuals, severe sleep quality and quantity disruption can cause neurological problems and increased morbidity. After discharge, critically sick individuals may develop acute anxiety and depression due to sleep deprivation.
Melatonin, the pineal gland's major neurohormone, regulates circadian rhythm is anti-inflammatory, antitoxic, hypnotic, anticonvulsive, sedative, and analgesic. Due to noise, 24-hour artificial light, limited natural light, more severe disease severity than general wards, and widespread use of sedative and narcotic drugs, intensive care unit patients' melatonin secretion is severely suppressed. These factors can increase nocturnal wakefulness, shorten sleep, and lower sleep quality. Sleep deprivation alters the sleep-wake cycle, and aberrant melatonin excretion is linked to delirium, a common organ malfunction that affects 45% to 87% of intensive care patients. Delirium is characterized by impaired consciousness with cognitive changes (hyperactive, hypoactive, or mixed) and is associated with longer mechanical ventilation and intensive care time, higher mortality, cognitive sequelae, and higher hospital costs. Sleep deprivation and delirium influence the prefrontal and parietal cortices of the central nervous system, causing neurohormonal alterations such as decreased acetylcholine or increased dopamine. It will be believed sleep can cause delirium.
Because sleep and delirium share processes, this study examines how preoperative sleep quality affects postoperative delirium in over 45 and elderly patients over 65 who receive general anaesthesia. Second, it'll be assessed for postoperative sleep and healing.
- Keywords
- General anesthesia, Delirium, Perioperative neurocognitive disorders, Sleep Quality
- Medical subject headings
- Delirium, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Over 45 year old | Before surgery All preoperative patients will have Preoperative Stop Bang, Pittsburghb Sleep Quality Index, and Mini Mental tests for sleep quality and consciousness monitoring. This will be based on sleep the day before surgery and mini-mental exams before surgery. The intraoperative phase Our clinical approach is to admit patients under general anesthesia after regular assessment and monitoring. The following parameters will be recorded intraoperatively. After surgery As usual, patients are brought to the PACU after awakening. It will be measured Pittsburghb Sleep Quality Index on 3 days, QoR-15 on the last day, and 3D CAM or ICU-CAM for 3 days postoperatively. Patients will stay in the ward and intensive care unit for 72 hours and be called for 72 hours after release. | |
| Over 65 year old | Before surgery All preoperative patients will have Preoperative Stop Bang, Pittsburghb Sleep Quality Index, and Mini Mental tests for sleep quality and consciousness monitoring. This will be based on sleep the day before surgery and mini-mental exams before surgery. The intraoperative phase Our clinical approach is to admit patients under general anesthesia after regular assessment and monitoring. The following parameters will be recorded intraoperatively. After surgery As usual, patients are brought to the PACU after awakening. It will be measured Pittsburghb Sleep Quality Index on 3 days, QoR-15 on the last day, and 3D CAM or ICU-CAM for 3 days postoperatively. Patients will stay in the ward and intensive care unit for 72 hours and be called for 72 hours after release. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality and delirium index
Will be evaluate the relationship between preoperative sleep quality and postoperative delirium.
Measured: Preoperative, and post operative period up to 3 days.
Secondary outcomes (1)
Preop. and postop. sleep quality index
Will be evaluate the effect of preoperative sleep quality on postoperative sleep quality
Measured: Preoperative, and post operative period up to 3 days..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Aug 2023
- Primary completion18 Dec 2023
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUMStudies 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
- 150 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Tire, MD, Konya City Hospital
- Investigators
- Yasin Tire, Assoc. Prof., Principal investigator, Konya City HospitalDilek Ateş, MD, Study director, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273358
- Sponsor's protocol ID
- Study Sleep Quality
- Status last verified
- Feb 2024
- First submitted
- 14 Dec 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Sleep Quality on Postoperative Delirium Status in Adult Patients
- ClinicalTrials.gov ID
- NCT06273358
- Acronym / sponsor ID
- Study Sleep Quality
- Keywords
- General anesthesia, Delirium, Perioperative neurocognitive disorders, Sleep Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 22 Feb 2024 (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.
Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.
Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years [SD]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean.
Detailed description
The global old population has grown as life quality has improved. According to WHO and UN publications, people 65 and older are mostly examined, and 60 and older are examined. The Turkish Statistical Institute (TUIK) reports 8 million,245 thousand 124 senior people in Turkey as of December 31, 2022. In December 2021, 9.7% of the population was 65 or older.
In 2021, 9.56% of the global population was 65 or older. Countries' aging processes vary. In 2021, 28.7% of Japan's population was elderly, while the United Arab Emirates had 1.4%. The rate of elderly patients over 65 obtaining general anesthesia for surgery has also grown. Noncardiac surgery often causes delirium in 10-40% of patients. Delirium increases the likelihood of postoperative mortality and poor neurocognitive recovery. The patient, family, and healthcare system are affected by postoperative delirium.
Delirium is difficult to avoid and cure because to its unknown pathophysiology. Evidence suggests that age, frailty, comorbidities, and substance addiction are predisposing and triggering factors. Other risk factors for delirium include perioperative opioid and benzodiazepine usage, operation severity and type, extreme pain, neuroinflammation, and electrolyte problems. Delirium in critically ill individuals is characterized by organ malfunction, acute-onset cognitive impairment, visual hallucinations, delusions, and illusions.
Initial cognitive impairment, acute sickness, dehydration, and aging enhance hospitalized patient delirium. Male gender, alcohol addiction, fractures, depression, visual impairments, and dementia predispose to delirium; restraint, nutritional disorders, multiple medications, urinary catheter, infections, too much or too little sensory stimulation (social isolation), noise, pain, neuroleptics or narcotics, frequent hospital room changes, no clock, no glasses, Surgery, medical procedures, and intensive care can cause delirium (2,16-18).
Critically sick individuals have poor sleep quality and quantity. Sleep disturbances can have a substantial personal and socioeconomic impact on people with respiratory, cardiovascular, metabolic, and mental diseases. In critically ill individuals, severe sleep quality and quantity disruption can cause neurological problems and increased morbidity. After discharge, critically sick individuals may develop acute anxiety and depression due to sleep deprivation.
Melatonin, the pineal gland's major neurohormone, regulates circadian rhythm is anti-inflammatory, antitoxic, hypnotic, anticonvulsive, sedative, and analgesic. Due to noise, 24-hour artificial light, limited natural light, more severe disease severity than general wards, and widespread use of sedative and narcotic drugs, intensive care unit patients' melatonin secretion is severely suppressed. These factors can increase nocturnal wakefulness, shorten sleep, and lower sleep quality. Sleep deprivation alters the sleep-wake cycle, and aberrant melatonin excretion is linked to delirium, a common organ malfunction that affects 45% to 87% of intensive care patients. Delirium is characterized by impaired consciousness with cognitive changes (hyperactive, hypoactive, or mixed) and is associated with longer mechanical ventilation and intensive care time, higher mortality, cognitive sequelae, and higher hospital costs. Sleep deprivation and delirium influence the prefrontal and parietal cortices of the central nervous system, causing neurohormonal alterations such as decreased acetylcholine or increased dopamine. It will be believed sleep can cause delirium.
Because sleep and delirium share processes, this study examines how preoperative sleep quality affects postoperative delirium in over 45 and elderly patients over 65 who receive general anaesthesia. Second, it'll be assessed for postoperative sleep and healing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Over 45 year old | – | –Before surgery All preoperative patients will have Preoperative Stop Bang, Pittsburghb Sleep Quality Index, and Mini Mental tests for sleep quality and consciousness monitoring. This will be based on sleep the day before surgery and mini-mental exams before surgery. The intraoperative phase Our clinical approach is to admit patients under general anesthesia after regular assessment and monitoring. The following parameters will be recorded intraoperatively. After surgery As usual, patients are brought to the PACU after awakening. It will be measured Pittsburghb Sleep Quality Index on 3 days, QoR-15 on the last day, and 3D CAM or ICU-CAM for 3 days postoperatively. Patients will stay in the ward and intensive care unit for 72 hours and be called for 72 hours after release. |
| Over 65 year old | – | –Before surgery All preoperative patients will have Preoperative Stop Bang, Pittsburghb Sleep Quality Index, and Mini Mental tests for sleep quality and consciousness monitoring. This will be based on sleep the day before surgery and mini-mental exams before surgery. The intraoperative phase Our clinical approach is to admit patients under general anesthesia after regular assessment and monitoring. The following parameters will be recorded intraoperatively. After surgery As usual, patients are brought to the PACU after awakening. It will be measured Pittsburghb Sleep Quality Index on 3 days, QoR-15 on the last day, and 3D CAM or ICU-CAM for 3 days postoperatively. Patients will stay in the ward and intensive care unit for 72 hours and be called for 72 hours after release. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the sample size analysis, it was determined that there should be 72 patients for each group with an alpha margin of error of 0.05, with a power rate of 80% for comparison of two groups. The effect used for this calculation was calculated as 0.417, and the actual power was calculated as 0.801, based on similar studies. As a result of the analysis, considering the drop out rate, it was planned to include 75 patients for each group.
Key inclusion criteria (5 listed)
- Patients will be eligible if:
Key exclusion criteria (6 listed)
- Patients will not be eligible if:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep quality and delirium index
Time frame: Preoperative, and post operative period up to 3 days.
Will be evaluate the relationship between preoperative sleep quality and postoperative delirium.
1 secondary outcome
Preop. and postop. sleep quality index
Time frame: Preoperative, and post operative period up to 3 days..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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. This study is not recruiting at the moment.
Yasin Tire, Assoc. Prof. principal investigator
Konya City Hospital
Dilek Ateş, MD study director
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality and delirium index (time frame: Preoperative, and post operative period up to 3 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 22 Feb 2024.