Sleep DisorderNCT06269328
Measuring Sleep Quality In Patients That Posterior Spinal Instrumentatıon Plannıng
A study testing Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance and Inhalation anesthesia with sevoflurane for anesthetic maintenance in people with Sleep Disorder and Sleep, Inadequate, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Sleep, Inadequate, Total ıntravenous Anesthesia
- What is being tested?
- Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance and Inhalation anesthesia with sevoflurane for anesthetic maintenance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jan 2024
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective total hip arthroplasty planning
- 18 years and older patients
- ASA score between I-III
- Approved and signed the informed consent form
Who cannot join
- Patients under 18 years of age
- Patients with ASA score 4 and above
- Patients who do not accept informed consent
- Those who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluatıon The Effects Of Anesthesıcs And Surgıcal Treatment On Sleep Qualıty In Patıents That Posterıor Spınal Instrumentatıon Plannıng
Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort.
Read the detailed description
Sleep is one of the basic physiological needs of humans. It is necessary for the mind to perform functions such as learning, memory and cognition. Sleep disorders, which can occur for short or long periods in the perioperative period, affect many patients. Studies have shown that approximately 8.8-79.1% of patients experience perioperative sleep disorders, and this situation can continue for a long time after surgery.
According to animal and human studies, anesthetic agents may cause sleep disorders in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause insomnia and poor sleep quality. Since postoperative pain and emotional changes will also cause sleep disturbances, the view that general anesthesia impairs postoperative sleep quality has not yet been proven.
Different types of surgery have varying effects on sleep quality. Patients state that they experience more sleep disruption due to pain, especially after orthopedic surgery. Patients' sleep quality may be even worse due to the greater trauma caused by major surgery. Thoracolumbar posterior instrumentation is a frequently used method in the treatment of spinal instability resulting from spinal trauma, neoplasia, congenital or degenerative diseases. Therefore, we wanted to specifically evaluate this patient group in our study.
Old age, female gender and chronic diseases are among the factors that increase the likelihood of experiencing sleep disorders. Environmental factors and healthcare practices in the hospital may contribute to sleep disturbances. Postoperative environment change, inadequate beds, noise and lights in the ward, medical staff, night treatment and nursing controls, machine noises, postoperative diets and warnings from the urinary catheter are additional factors that affect patients' sleep.
Evaluation of sleep disorders is mainly based on clinical symptoms (difficulty falling asleep, early awakening, night terrors, nightmares or abnormal behavior during the sleep period) and auxiliary objective scales. Subjective sleep quality assessment mainly scales: Pittsburgh Sleep Quality Index questionnaire (PSQI), Pittsburgh Insomnia Rating Scale (PIRS), Insomnia Severity Index (ISI), Athens Insomnia Scale, Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS). The most commonly used assessment in clinical studies is the PSQI. PSQI has high reliability and validity, but evaluates over a one-month period. The PIRS_20 scale, which is a self-assessment survey, is a scale created by the Department of Psychiatry at the University of Pittsburgh and evaluates the sleep quality of participants in the last week. It generally consists of a questionnaire with a total of twenty items, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disorders. Scoring ranges from 0 to 60. A score of 20 and above indicates poor sleep quality, while as the score increases, sleep quality deteriorates.
Sleep disorders can negatively impact patient recovery, contributing to higher rates of postoperative complications such as neurological and cardiovascular morbidity and delayed postoperative recovery. They are also risk factors for cardiovascular and cerebrovascular diseases such as myocardial infarction, as well as dementia, obesity, diabetes, hypertension, depression, pain and even death. It is also considered an important risk factor for the development of delirium. Despite posing a significant threat to public health, sleep disorders remain poorly understood, underdiagnosed, and poorly managed, especially in perioperative patients. The potential negative consequences of sleep disorders indicate the need for greater attention to this issue.
Despite its importance, sleep quality assessment is not a part of the routine preoperative evaluation of patients and does not receive enough attention. Peroperative sleep assessment can provide information for anesthesiologists and surgeons that may allow early interventions. There are no guidelines or sufficient number of studies for clinical use.
In this study, PIRS-20 (Pittsburg Insomnia Rating Scale_20), VAS (Visual Analog Scale), State Anxiety Scale (STAI-1) will be used. In addition, the Oswestry Functional Disability Scale, SRS-22 (Scoliosis Research Society-22) questionnaire, EQ-5D-5L General Quality of Life Scale, SF-36 Quality of Life Scale, which are routinely used in orthopedic clinics, are used to evaluate anesthesia and surgery in patients undergoing posterior spinal instrumentation. The investigators aimed to evaluate changes in sleep patterns caused by trauma and simultaneously anxiety and pain levels.
The aim of this research is to evaluate how major orthopedic surgery and general anesthesia affect the sleep quality of patients who underwent posterior spinal instrumentation.
The primary hypothesis of this study is that total intravenous anesthesia with propofol and remifentanil is superior to inhalation anesthesia with sevoflurane in terms of sleep quality. In this process, the investigators aimed to identify risk factors for patients, thus improving surgical results and patient comfort.
- Being tested
- Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance, Inhalation anesthesia with sevoflurane for anesthetic maintenance
- Keywords
- Anesthesia, General anesthesia, Sleep quality, Total ıntravenous anesthesia, Inhalation anesthesia
- Medical subject headings
- Sleep Wake Disorders, Sleep Deprivation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenanceOther
For anesthesia induction, intravenous propofol was used at doses of 1-2 mg/kg, fentanyl at 2mcg/kg, lidocaine at 1mg/kg, and rocuronium at doses of 1mg/kg. After then anesthesia maintained with propofol iv 75-100 µg kg-1 min-1 and remifentanyl iv 0.05-0.2 µg kg-1 min-1 infusion.
Inhalation anesthesia with sevoflurane for anesthetic maintenanceOther
For anesthesia induction, intravenous propofol was used at doses of 1-2 mg/kg, fentanyl at 2mcg/kg, lidocaine at 1mg/kg, and rocuronium at doses of 1mg/kg. After then anesthesia was maintained with inhalation anesthetic (50% O2/Air with Sevoflurane 2% )
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Active comparator | Patients will be anesthetized with total ıntravenous anesthesia by propofol and remifentanyl infusion. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period. Receives: Other: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance |
| İnhalation group | Active comparator | Patients will be anesthetized with induction of propofol and sevoflurane (inhalational agent) will be used for maintenance. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period. Receives: Other: Inhalation anesthesia with sevoflurane for anesthetic maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale)
Sleep quality evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) , a scale provides ranging from 0 to 60 , with a high score indicating a poor quality of sleeping.
Measured: Preoperative status a month before surgery and a day before surgery and one week postoperatively]
Secondary outcomes (2)
Subjective anxiety level
Anxiety level evaluated by STAI (The State Trait Anxiety Inventory), a scale provides ranging from 20 to 80, with a high score indicating high levels of anxiety.
Measured: Preoperative status a month before surgery and a day before surgery and one week postoperatively]
Subjective pain level
Pain level evaluated by VAS (Visuel analog scale) , a scale provides ranging from 0 to 10, with a high score indicating high levels of pain.
Measured: Preoperative status a month before surgery and a day before surgery and one week postoperatively]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Jul 2022
- Primary completion1 Sep 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elifgül Ulutaş, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269328
- Sponsor's protocol ID
- 2011-KAEK-26/463
- Status last verified
- Jul 2022
- First submitted
- 13 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon The Effects Of Anesthesıcs And Surgıcal Treatment On Sleep Qualıty In Patıents That Posterıor Spınal Instrumentatıon Plannıng
- ClinicalTrials.gov ID
- NCT06269328
- Acronym / sponsor ID
- 2011-KAEK-26/463
- Keywords
- Anesthesia, General anesthesia, Sleep quality, Total ıntravenous anesthesia, Inhalation anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 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.
Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort.
Detailed description
Sleep is one of the basic physiological needs of humans. It is necessary for the mind to perform functions such as learning, memory and cognition. Sleep disorders, which can occur for short or long periods in the perioperative period, affect many patients. Studies have shown that approximately 8.8-79.1% of patients experience perioperative sleep disorders, and this situation can continue for a long time after surgery.
According to animal and human studies, anesthetic agents may cause sleep disorders in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause insomnia and poor sleep quality. Since postoperative pain and emotional changes will also cause sleep disturbances, the view that general anesthesia impairs postoperative sleep quality has not yet been proven.
Different types of surgery have varying effects on sleep quality. Patients state that they experience more sleep disruption due to pain, especially after orthopedic surgery. Patients' sleep quality may be even worse due to the greater trauma caused by major surgery. Thoracolumbar posterior instrumentation is a frequently used method in the treatment of spinal instability resulting from spinal trauma, neoplasia, congenital or degenerative diseases. Therefore, we wanted to specifically evaluate this patient group in our study.
Old age, female gender and chronic diseases are among the factors that increase the likelihood of experiencing sleep disorders. Environmental factors and healthcare practices in the hospital may contribute to sleep disturbances. Postoperative environment change, inadequate beds, noise and lights in the ward, medical staff, night treatment and nursing controls, machine noises, postoperative diets and warnings from the urinary catheter are additional factors that affect patients' sleep.
Evaluation of sleep disorders is mainly based on clinical symptoms (difficulty falling asleep, early awakening, night terrors, nightmares or abnormal behavior during the sleep period) and auxiliary objective scales. Subjective sleep quality assessment mainly scales: Pittsburgh Sleep Quality Index questionnaire (PSQI), Pittsburgh Insomnia Rating Scale (PIRS), Insomnia Severity Index (ISI), Athens Insomnia Scale, Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS). The most commonly used assessment in clinical studies is the PSQI. PSQI has high reliability and validity, but evaluates over a one-month period. The PIRS_20 scale, which is a self-assessment survey, is a scale created by the Department of Psychiatry at the University of Pittsburgh and evaluates the sleep quality of participants in the last week. It generally consists of a questionnaire with a total of twenty items, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disorders. Scoring ranges from 0 to 60. A score of 20 and above indicates poor sleep quality, while as the score increases, sleep quality deteriorates.
Sleep disorders can negatively impact patient recovery, contributing to higher rates of postoperative complications such as neurological and cardiovascular morbidity and delayed postoperative recovery. They are also risk factors for cardiovascular and cerebrovascular diseases such as myocardial infarction, as well as dementia, obesity, diabetes, hypertension, depression, pain and even death. It is also considered an important risk factor for the development of delirium. Despite posing a significant threat to public health, sleep disorders remain poorly understood, underdiagnosed, and poorly managed, especially in perioperative patients. The potential negative consequences of sleep disorders indicate the need for greater attention to this issue.
Despite its importance, sleep quality assessment is not a part of the routine preoperative evaluation of patients and does not receive enough attention. Peroperative sleep assessment can provide information for anesthesiologists and surgeons that may allow early interventions. There are no guidelines or sufficient number of studies for clinical use.
In this study, PIRS-20 (Pittsburg Insomnia Rating Scale_20), VAS (Visual Analog Scale), State Anxiety Scale (STAI-1) will be used. In addition, the Oswestry Functional Disability Scale, SRS-22 (Scoliosis Research Society-22) questionnaire, EQ-5D-5L General Quality of Life Scale, SF-36 Quality of Life Scale, which are routinely used in orthopedic clinics, are used to evaluate anesthesia and surgery in patients undergoing posterior spinal instrumentation. The investigators aimed to evaluate changes in sleep patterns caused by trauma and simultaneously anxiety and pain levels.
The aim of this research is to evaluate how major orthopedic surgery and general anesthesia affect the sleep quality of patients who underwent posterior spinal instrumentation.
The primary hypothesis of this study is that total intravenous anesthesia with propofol and remifentanil is superior to inhalation anesthesia with sevoflurane in terms of sleep quality. In this process, the investigators aimed to identify risk factors for patients, thus improving surgical results and patient comfort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Active comparator | Other: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenancePatients will be anesthetized with total ıntravenous anesthesia by propofol and remifentanyl infusion. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period. |
| İnhalation group | Active comparator | Other: Inhalation anesthesia with sevoflurane for anesthetic maintenancePatients will be anesthetized with induction of propofol and sevoflurane (inhalational agent) will be used for maintenance. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective total hip arthroplasty planning
- 18 years and older patients
- ASA score between I-III
- Approved and signed the informed consent form
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Patients with ASA score 4 and above
- Patients who do not accept informed consent
- Those who refuse to participate in 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 |
|---|---|---|
| Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenanceFor anesthesia induction, intravenous propofol was used at doses of 1-2 mg/kg, fentanyl at 2mcg/kg, lidocaine at 1mg/kg, and rocuronium at doses of 1mg/kg. After then anesthesia maintained with propofol iv 75-100 µg kg-1 min-1 and remifentanyl iv 0.05-0.2 µg kg-1 min-1 infusion. | Other | TIVA group |
| Inhalation anesthesia with sevoflurane for anesthetic maintenanceFor anesthesia induction, intravenous propofol was used at doses of 1-2 mg/kg, fentanyl at 2mcg/kg, lidocaine at 1mg/kg, and rocuronium at doses of 1mg/kg. After then anesthesia was maintained with inhalation anesthetic (50% O2/Air with Sevoflurane 2% ) | Other | İnhalation group |
Primary outcome
Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale)
Time frame: Preoperative status a month before surgery and a day before surgery and one week postoperatively]
Sleep quality evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) , a scale provides ranging from 0 to 60 , with a high score indicating a poor quality of sleeping.
2 secondary outcomes
Subjective anxiety level
Time frame: Preoperative status a month before surgery and a day before surgery and one week postoperatively]
Subjective pain level
Time frame: Preoperative status a month before surgery and a day before surgery and one week postoperatively]
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 28 Feb 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance and Inhalation anesthesia with sevoflurane for anesthetic maintenance in people with Sleep Disorder and Sleep, Inadequate, run by Uludag University 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 4 inclusion and 4 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 28 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?
Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) (time frame: Preoperative status a month before surgery and a day before surgery and one week postoperatively]). 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 28 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.