Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06041711 |
| Other study ID # |
2011-KAEK-26 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 21, 2022 |
| Est. completion date |
October 28, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Uludag University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
