Surgery for Sleep Disordered Breathing
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Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Male and female military health care beneficiaries between the ages of 18 and 85 years presenting for elective ambulatory orthopedic surgery at WRNMMC main operating room. Exclusion Criteria: Patients who are pregnant or breast-feeding at the time of the procedure.
Pregnancy will be ruled out by day of surgery urine human chorionic gonadotropin HCG when appropriate.
Surgery for Sleep Disordered Breathing
Chronic opioid, benzodiazepine, pregabalin, or other sedating medication users Chronic alcohol users defined by daily or greater use upon standard anesthesia preoperative interview Patients who require home oxygen use Patients who have a tracheostomy Patients who decline to participate. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information.
Publications automatically indexed to this study by ClinicalTrials. J Clin Sleep Med. OSA Sleep disordered breathing anesthesia ambulatory orthopedic surgery. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
Surgery for Sleep-Disordered Breathing | SpringerLink
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Sleep Disordered Breathing. Other: Home sleep test administered to all enrolled subjects.
Study Type :. Actual Enrollment :. Skip to main navigation Skip to main content Skip to footer. Symptom Checker. Find an ENT. Type and Press Enter to Search Close. Pediatric Sleep-disordered Breathing. Potential symptoms and consequences of untreated pediatric SDB may include: Snoring —The most obvious symptom of SDB is loud snoring that is present on most nights. The snoring can be interrupted by complete blockage of breathing, with gasping and snorting noises associated with waking up from sleep.
Loud snoring can also become a significant social problem if a child shares a room with siblings, or at sleepovers and summer camp.
What Are the Symptoms of Pediatric SDB?
Irritability —A child with SDB may become irritable, sleepy during the day, or have difficulty concentrating in school. He or she may also display busy or hyperactive behavior. Bedwetting —SDB can cause increased urine production at night, which may lead to bedwetting also called enuresis. Learning difficulties —Children with SDB may become moody and disruptive, or not pay attention, both at home and at school. SDB can also be a contributing factor to attention deficit disorders in some children.
Slow growth —Children with SDB may not produce enough growth hormone, resulting in abnormally slow growth and development. Cardiovascular difficulties —OSA can be associated with an increased risk of high blood pressure, or other heart and lung problems. Obesity —SDB may cause the body to have increased resistance to insulin, and daytime fatigue can lead to decreased physical activity.
These factors can contribute to obesity. How is Sleep Apnea Diagnosed? Long-term biopsy studies have not shown increased risk of nasal mucosal atrophy, ulceration or septal perforation, although post-marketing data has demonstrated rare cases Good nasal spray technique, such as pointing the nozzle away from the nasal septum, may minimise these local reactions Consistent with the low bioavailability of these agents, studies have found no evidence of hypothalamic-pituitary axis damage, reductions in bone density or eye complications, such as cataracts INCS are well tolerated, with very low risk of serious adverse events and attention to technique is recommended.
Both the benzodiazepine and non-benzodiazepine drugs act on the neurotransmitter gamma-aminobutyric acid GABA receptors throughout the central nervous system. There are very few studies, however, directly comparing benzodiazepine to non-benzodiazepine drugs for adverse events.
Eszopiclone used on a titration night results in better titration according to several polysomnographic measures, such as sleep efficiency on the titration night. In another study, a two-week course of ezopiclone increased CPAP use by 1. A recent Cochrane review evaluating safety in OSA 62 showed no difference in the AHI or overnight oxygenation between the medication and placebo. This means that this group of drugs does not appear to worsen SDB. In a study by Eckert et al. The authors measured arousal threshold using an epiglottic pressure catheter and found that those with the greatest reduction in AHI had low arousal thresholds.
Those people with severe disease usually had a high arousal threshold, so are most at risk for deleterious reactions to sedatives, yet they were not included in this or other studies. In another study evaluating the effect of zolpidem on AHI, supratherapeutic doses lowered oxygen saturations minimum oxygen saturation: The Cochrane review authors note limitations in study design The studies were relatively short-term active agent for one night or two consecutive nights and the confidence intervals were wide, meaning that these agents could increase the AHI.
Gastro-intestinal discomfort, headaches, somnolence and dizziness are also reported Serious adverse effects are uncommon. Most of these were unrelated to the drug. Adverse events picked up in the post-marketing data also highlight central nervous system effects such as worsening depression, neurocognitive changes, delirium and confusion 68 - While RCTs exclude those with certain medical conditions such as psychiatric conditions, post-marketing data would suggest that those with psychiatric conditions see a Psychiatrist before starting medication.
Evaluation of Sleep Disordered Breathing Following Ambulatory Surgery
Increasing the dose increases the risk, as does female gender and older age Product information warns of this possibility and not to drive or operate dangerous machinery until it is known that they do not become drowsy after therapy The risks of hangover effects are related to drug factors, such as dose and half-life and patient characteristics with extra care needed in the elderly, females and those on multiple medications, especially other psychoactive drugs As an example of post-marketing data picking up events not identified in the RCTs, an observational study using health administration data found that use of zolpidem in the elderly was associated with a doubling of the risk of hip fracture after controlling for confounding factors In elderly patients, it is recommended to use the 5 mg zolpidem dose rather than 10 mg For some patients with clinically relevant sleepiness despite seemingly good CPAP use, the American Sleep Academy recommends Modafinil 74 providing other identifiable causes of sleepiness have been excluded.
Recent meta-analyses of RCTs for this indication, such as Chapman et al. However, there was a higher rate of adverse events in the active agents with a 1. The number of serious adverse events was small not significantly different between active and placebo groups and there were no deaths. Small rises in systolic 3 mmHg and diastolic 1. A major limitation of the meta-analysis was a lack of long-term safety data because the trials were not longer than three months.
There were no clinically significant increases in heart rate and few patients had clinically significant electrocardiogram ECG changes. Of 15 serious adverse events, four possibly were related to the drug and included nonspecific chest pain, pulmonary embolism, myocardial infarction and exacerbation of depression. The product information for armodafinil 77 notes that in the clinical studies there were three patients with underlying heart conditions, for example mitral valve prolapse and left ventricular hypertrophy, who developed signs such as palpitations or ECG changes.
Post-marketing data indicate that psychiatric adverse reactions can occur, often in those with a prior history of psychiatric disease. It is recommended that caution be exercised in those with known cardiac or psychiatric disease. There is no evidence from RCTs that polysomnographic sleep architecture is affected, but a concern is that CPAP may not be utilised as much.
However, in a week RCT by Roth et al. The potential for abuse of these drugs is thought to be relatively low 77 , 79 but euphoric effects can occur and may be a reason for abuse Care should be taken in patients with a history of drug abuse and an awareness of drug-seeking behaviour is advised Drug interactions can occur, including cytochrome P induction, rendering oral contraceptive pills ineffective. Barrier contraceptive methods are recommended as this medication is contraindicated in pregnancy. Barrier or other methods need to be continued for a month after stopping the medication Post marketing data has revealed rare but potentially life-threatening rashes, including Stevens-Johnson Syndrome, that occur above the background rate of these conditions in the population These drugs are associated with modest improvements in those with residual sleepiness on CPAP, they are generally well tolerated, but caution is needed with cardiovascular and psychiatric conditions, and rare and potentially life-threatening reactions can occur.
In conclusion, adjunctive medications can improve outcomes in subgroups of patients with OSA but careful patient selection and close supervision are needed because serious adverse effects can occur. A medical model is recommended for the safe use of adjunctive medications and those seeking OSA treatment outside this model for example, those going directly to a pharmacy are likely to miss out on the benefits of these medications.
Factors contributing to complications in OSA surgery are broadly outlined in Table 3. Contemporary airway surgery encompasses a broad range of procedures, reflecting heterogeneity in patient anatomy, in the disease, and in experience of the surgical team. Anatomical heterogeneity makes the art of patient selection for surgery difficult, and the interpretation of the science of the literature vexed. Most publications in surgery look only at single level surgery, rather than multi-level, which is more reflective of real-life surgery.