Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
Stopped early · Phase 2/Phase 3
Conditions studied: Sleep Apnea, Obstructive Sleep Apnea, Postoperative Complications
In brief
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.
Key facts
- Study ID
- NCT03109418
- Run by
- University of Alabama at Birmingham
- People needed
- 9
- Starts
- 2016-06-02
- Expected to finish
- 2018-09-12
- Last updated by the study team
- 2019-12-19
Who can join
Age: 19 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- aged 19-100
- scheduled to undergo general ENT or Orthopedic Surgery
- diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).
You may not qualify if…
- positive pregnancy test
- ASA > III
- history of alcohol or narcotic abuse in last 90 days
- significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%)
- significant psychiatric or neurologic disease
- history of significant hepatic or renal disease (baseline creatinine>1.5)
- history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP
- increased IOP
- severe arrhythmias
- history of delirium
- history of hallucinations
- history of psychosis
- history of uncontrolled seizures
- potential risk for malignant hyperthermia (family history)
- history of difficult intubation that would preclude standard induction of anesthesia
- prisoners
- persons who are mentally impaired
- non-English speakers
Where it is running
- UAB Department of Anesthesiology and Perioperative Medicine — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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