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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Yasin Tire

    Konya, Meram, 42140

Other trials in Turkey (Türkiye)

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 groups in NCT06273358
Study groupRoleWhat they receive
Over 45 year oldBefore 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 oldBefore 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.

  1. 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)
  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.

  1. First posted22 Feb 2024
  2. Study start1 Aug 2023
  3. Primary completion18 Dec 2023
  4. Study completion27 Jan 2024

Resources

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
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

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.

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