Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea



Status:Completed
Conditions:Insomnia Sleep Studies, Hospital, Pulmonary, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:19 - 100
Updated:10/18/2018
Start Date:June 2, 2016
End Date:September 12, 2018

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Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study

The aim of this study is to substantially reduce overall postoperative morbidity and
mortality associated with obstructive sleep apnea.

Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is
not a well-established, general anesthetic technique that clearly decreases the risk of
postoperative respiratory complications in these patients. If OSA patients have significantly
decreased postoperative opioid requirements and improved recovery profiles in the PACU, the
protocol could have significant implications in defining future standardized general
anesthesia recommendations for patients with this disease. Ultimately, the aim of this study
is to substantially reduce overall postoperative morbidity and mortality associated with
obstructive sleep apnea. The objective of this study is to compare the postoperative recovery
profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline
infusion versus Sevoflurane combined with a low-dose ketamine infusion.

Inclusion Criteria:

- 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 ).

Exclusion Criteria:

- 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
We found this trial at
1
site
Birmingham, Alabama 35249
Principal Investigator: Peter A Nagi, MD
Phone: 205-934-4711
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from
Birmingham, AL
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