Clinical trial NCT03613558: Dex as Analgesic Adjuvant in OSA Patients
Official title: A Double Blinded Randomized Placebo Controlled Study Evaluating the Use of Intraoperative Dexmedetomidine in Reducing Postoperative Pain and Narcotic Requirement in Patients With Moderate to Severe OSA.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea
Keywords: Dexmedetomidine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Score
timeFrame: within 24 hours post-operative
Secondary outcomes:
measure: Pain Score
timeFrame: within 24 hours post-operative
measure: Nausea
timeFrame: within 24 hours post-operative
measure: Hypoxia
timeFrame: within 24 hours post-operative
measure: Length of hospital stay
timeFrame: from admission to discharge, up to 14 days
measure: Sedation
timeFrame: within 24 hours post-operative
measure: Time to extubation
timeFrame: from post-operative until extubation, up to 72 hours
measure: Number of participants experiencing vomiting
timeFrame: within 24 hours post-operative
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Tracey Straker, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: FDA. (2012, August 15) FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. FDA.gov Retrieved August 8, 2013 from http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm#safety.