Obstructive Sleep Apnea
Conditions
Keywords
Dexmedetomidine
Brief summary
The purpose of this study is to assess whether intravenous peri-operative Dexmedetomidine reduces opioid requirements and or improves pain control after Uvulopalatopharyngoplasty (UPPP) in patients with obstructive sleep apnea (OSA).
Detailed description
BACKGROUND/STUDY SIGNIFICANCE Patients with OSA undergoing surgery have increased surgical risk compared to patients that do not have OSA . Perioperative medication such as benzodiazepines and opioids can decrease upper airway tone, inhibit central respiratory drive and inhibit upper airway reflexes. The supine position may also worsen the severity of the OSA. Additionally, this group of patients is more likely to have a higher incidence of complications, particularly post operative hypoxemia , difficult intubation , and complicated extubation course . Uvulopalatopharyngoplasty (UPPP) along with other tongue base procedures are commonly performed surgical procedures used to help alleviate the symptoms of obstructive sleep apnea (OSA). Postoperative management of oropharyngeal pain is challenging since narcotic administration may compromise respiratory status in OSA patients. The Anesthesiology and Otorhinolaryngology communities have begun to rethink acceptable narcotic use in OSA patients especially following the recent FDA announcement highlighting serious adverse effects related to codeine consumption in children who had undergone tonsillectomies. Dexmedetomidine (Precedex) is a sedative with minimal respiratory depression. Its mechanism is via alpha 2 agonism and has 8 times the affinity for the alpha 2 adrenoreceptor than clonidine. It has been shown to have sedative, analgesic, and anxiolytic effects. It produces a predictable and dose dependent decrease in heart rate and blood pressure. Dexmedetomidine undergoes extensive metabolism in the liver and is then eliminated as methyl and glucuronide conjugates mostly via the renal system. The pharmacokinetics are markedly affected by hepatic insufficiency .
Interventions
DRUGDexmedetomidine
Dexmedetomidine is an alpha-2 agonist that provides both sedation and analgesia
DRUGPlacebo
saline solution
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Patients scheduled for UPPP * Patients with diagnosis of OSA via polysomnography * American Society of Anesthesiology (ASA) classification 3 or lower
Exclusion criteria
* Bradycardia as defined as resting heart rate \<60 Beats per min (BPM) or symptomatic * Any degree of heart block diagnosed by ECG * Hypotension as defined as \<20% from baseline or symptomatic * Liver failure, (two fold rise in liver enzymes) * Chronic Kidney Disease (CKD) III or greater * History of allergy to opioids or dexmedetomidine * ASA classification 4 or higher * ICU or Step down admission * Difficult airway as defined by previous history of difficult intubation or requiring a fiberoptic intubation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | within 24 hours post-operative | Patient self-reported pain scores will be measured immediately after awakening post-op using the Numerical Pain Rating Scale and opioid requirements using morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | within 24 hours post-operative | Pain score and opioid requirements will continue to be measured up to 24 hours postoperatively |
| Nausea | within 24 hours post-operative | participants experience of nausea will be reported |
| Hypoxia | within 24 hours post-operative | Number of hypoxic events will be calculated |
| Length of hospital stay | from admission to discharge, up to 14 days | Number of days spent in the hospital from admission to discharge will be assessed. |
| Sedation | within 24 hours post-operative | Ramsay Sedation Scale |
| Time to extubation | from post-operative until extubation, up to 72 hours | length of time from operation to removal of endotracheal tube will be measured |
| Number of participants experiencing vomiting | within 24 hours post-operative | participants' experiencing vomiting will be assessed and reported by care providers |
Countries
United States
Outcome results
None listed