AzTrials
AzTrials

Sleep DisturbanceNCT06041711

GENERAL vs. REGIONAL ANESTHESIA ON SLEEP QUALITY FOR HIP ARTROPLASTY PATIENTS

A study testing General anesthesia with propofol induction and sevoflurane maintenance and Regional anesthesia with neuroaxial blockage in people with Sleep Disturbance and Postoperative Complications, run by Uludag University 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
Search all trials

Trial summary

Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system.Sleep disorders, which may occur in the perioperative period as short-term or long-term, affect many patients. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
General anesthesia with propofol induction and sevoflurane maintenance and Regional anesthesia with neuroaxial blockage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Jul 2022to 28 Oct 2023
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

  • Planning of total hip arthroplasty (primary/redo)
  • Elective procedure planning
  • 18 years and older patients
  • ASA score between I-III
  • Approved and signed the informed consent form

Who cannot join

  • Patients who underwent THA with urgent indication
  • 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.

Turkey (Türkiye)1 site
  • Bursa Uludağ University Faculty of Medicine

    Bursa, Nilüfer, 16059

Other trials in Turkey (Türkiye)

About this study

Official title: COMPARISON OF THE EFFECTS OF GENERAL AND REGIONAL ANESTHESIA ON SLEEP QUALITY IN PATIENTS PLANNING TOTAL HIP ARTROPLASTY

Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system.Sleep disorders, which may occur in the perioperative period as short-term or long-term, affect many patients. Patients have to face with perioperative sleep disorders, and this situation can continue for a long time after surgery.

Anesthetic agents may cause sleep disturbances in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause sleep insufficiency and poor sleep quality. The relationship between general anesthesia and postoperative sleep disorders is still unclear. It is advantageous to identify patients with pre-existing sleep disorders, since the risk of postoperative sleep disturbance is high.

The investigators hypothesis that regional anesthesia does not disrupt the circadian rhythm compared to general anesthesia, is more successful in pain control, and thus provides a better sleep quality for patients.

Read the detailed description

Sleep is one of the basic physiological needs of man and is necessary for the normal functioning of the body. Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system. Sleep disorders, which may occur in the perioperative period as short-term or long-term, 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 disturbances in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause sleep insufficiency 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.

Pain is the most important risk factor for sleep disturbance in the perioperative period. There is a very serious interaction between pain and sleep. Pain can exacerbate sleep disorders. At the same time, sleep disorders can make the pain worse. Perioperative pain accompanies physical discomfort and is very common, especially in osteoarthritis patients. The goals of total hip arthroplasty (TKA) include relief of these pains and improvement of physical function.

Different types of surgery have varying effects on sleep quality. Patients report that they experience more sleep disruption due to pain after orthopedic surgery. Depending on the greater trauma caused by major surgery, the sleep quality of the patients may be worse.

The elderly and female gender are more likely to experience sleep disorders. Environmental factors and healthcare practices in the hospital may contribute to sleep disorders. 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). It is in the form. 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 participants' sleep quality 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. As another assessment of sleep quality, the ISI is a self-rating scale that measures insomnia symptoms and consequences. Substances include difficulties in initiating sleep and maintaining sleep; It is designed to assess satisfaction with current sleep patterns, disruption in daily life, cognitive impairments, and the degree of anxiety or worry caused by sleep disturbance. The severity of insomnia is also determined by the total score of these items. Additionally, ESS is used to evaluate the tendency to sleep during the day.

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 that more attention should be paid to this issue.

Risk factors that increase sleep problems include postoperative pain, depression, anxiety, and physical disabilities. Sleep problems experienced the night before surgery may affect postoperative pain due to various other factors. has an even more significant effect. Sleep quality assessment is not a part of the pre-anaesthesia routine evaluation of patients and adequate attention is not paid to perioperative management.

The type of anesthesia is also one of the factors on sleep quality. It is known that the anesthesia process (general anesthesia (GA) or regional anesthesia (RA)) affects melatonin rhythm. General anesthetics act centrally on the sleep center, causing sedation, hypnosis, and unconsciousness similar to a dreamless sleep. General anesthesia disrupts the sleep/wake cycle, other circadian rhythms such as body temperature regulation and melatonin secretion.

Regional anesthesia is thought to be more advantageous than general anesthesia in eliminating postoperative sleep disorders.

In this study, changes in sleep patterns and simultaneous changes in sleep patterns caused by regional and general anesthesia in patients who underwent total hip arthroplasty by using PID-20 (Pittsburg Insomnia Rating Scale_20), VAS (Visual Analogue Scale), Wong Baker Pain Scale, Momentary (State) Anxiety Scale scales. We aimed to evaluate anxiety and pain levels.

Despite the importance of sleep quality assessment, it is not a part of the routine pre-anesthesia evaluation of patients and does not receive enough attention. Preoperative sleep assessment can provide information that may allow early intervention by anesthetists. There are no guidelines and sufficient number of studies for clinical use.

Postoperative sleep disorders have serious effects on cognition, pain perception, altered circadian rhythm, psychomotor function, cardiovascular outcomes, metabolic function, catabolic responses, and inflammation. The relationship between general anesthesia and postoperative sleep disorders is still unclear. It is advantageous to identify patients with pre-existing sleep disorders, since the risk of postoperative sleep disturbance is high. The investigators hypothesis that regional anesthesia does not disrupt the circadian rhythm compared to general anesthesia, is more successful in pain control, and thus provides a better sleep quality for patients.

Protocol:

A total of 60 patients whom undergo total hip arthroplasty by Bursa Uludağ University Faculty of Medicine, Department of Orthopedics and Traumatology are included in this study.

Inclusion criteria: 18 years of age and older, score between I and III according to the American Society of Anesthesiologists (ASA) classification.

Exclusion criteria : Patients who underwent THA with urgent indication, patients under 18, ASA score 4 and above, patients who do not accept informed consent, those who refuse to participate in the study Patients are evaluated for sleep quality with the PID-20 (Pitssburg Insomnia Rating Scale) at least 1 month before the surgery date, and re-evaluated the night before and 1 week after the surgery. During this process, patients evaluated simultaneously with the VAS (Visual Analogue Scale), Wong Baker Pain Scale and Immediate (State) Anxiety Scale. The relationship between pain and anxiety and sleep quality are evaluated.

Patients are monitored in terms of possible complications, mortality and morbidity in the postoperative 3 months.

All evaluations are performed in the hospital where the patient is hospitalized and by the same anesthesiologist for a standard evaluation.

Demographic information (name-surname, protocol number, age, co-morbidity, medications used, habits, ASA score) of the patients are recorded. After the necessary information is given to the patients, their written and verbal consent is obtained.

Routine monitoring (electrocardiography, invasive/noninvasive blood pressure measurement, arterial blood gas monitoring, peripheral oxygen saturation, end-tidal carbon dioxide measurement with capnograph) are applied to the patients in the operating room in accordance with the standard protocol for elective total hip arthroplasty surgery, the anesthetic and analgesic drugs administered are recorded and hemodynamic changes in the intraoperative period (dysrhythmia, hypotension, hypertension), intraoperative complications (transfusion need, allergic reactions, etc.) are recorded. If lumbar combined spinal epidural anesthesia is applied for the regional anesthesia group, epidural patient-controlled analgesia is used in the postoperative period; If spinal anesthesia is applied, an additional PENG (pericapsular nerve group block) block is performed with the help of ultrasound and intravenous morphine patient-controlled analgesia used in the postoperative period. The general anesthesia group is extubated and awakened in the operating room, and intravenous morphine patient-controlled analgesia is used in the postoperative period.

In the postoperative period, intensive care unit stay, duration of hospital stay, early complications (pain, mobilization problems, hypertension, anxiety disorder, dysrhythmia, acute coronary syndrome, sepsis, pneumonia, infections, etc.) is followed up in the postoperative 3 months period.

Being tested
General anesthesia with propofol induction and sevoflurane maintenance, Regional anesthesia with neuroaxial blockage
Medical subject headings
Parasomnias, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General anesthesia with propofol induction and sevoflurane maintenanceProcedure or surgery

    Surgical procedure is performed under general anesthesia with propofol induction and mainteined with sevoflurane inhalation.

  • Regional anesthesia with neuroaxial blockageProcedure or surgery

    Surgical procedure is performed under regional anesthesia. Patients are sedated with 2 mg intravenous midazolam. Combined spinal epidural anesthesia or spinal anesthesia with PENG block is used for anesthesia and analgesia.

Study groups in NCT06041711
Study groupRoleWhat they receive
General anesthesia groupActive comparatorPatients allocated to the general anesthesia group will be subjected to general anesthesia with induction with propofol and will sevoflurane (inhalational agent) 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: Procedure: General anesthesia with propofol induction and sevoflurane maintenance
Regional anesthesia groupActive comparatorPatients allocated to the regional anesthesia group will be subjected to combined spinal-epidural anesthesia with heavy bupivacaine or spinal anesthesia with PENG(pericapsular nerve group) block with bupivacaine. If lumbar combined spinal epidural anesthesia is applied epidural patient-controlled analgesia will be used in the postoperative period. If spinal anesthesia and PENG block is applied, intravenous morphine patient-controlled analgesia will be used in the postoperative period.
Receives: Procedure: Regional anesthesia with neuroaxial blockage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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]

  2. 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.

  1. First posted18 Sep 2023
  2. Study start21 Jul 2022
  3. Primary completion5 Aug 2023
  4. Study completion28 Oct 2023

Resources

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
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06041711
Sponsor's protocol ID
2011-KAEK-26
Status last verified
Sep 2023
First submitted
30 Aug 2023
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing General anesthesia with propofol induction and sevoflurane maintenance and Regional anesthesia with neuroaxial blockage in people with Sleep Disturbance and Postoperative Complications, 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 5 inclusion and 5 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 14 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 14 Feb 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in