Clinical trial NCT03109418: Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
Official title: Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Sleep Apnea
Obstructive Sleep Apnea
Postoperative Complications
Keywords: Ketamine
Postoperative morbidity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores
timeFrame: up to 24 hours postoperatively
Secondary outcomes:
measure: Patient Satisfaction Score
timeFrame: At 24 hrs post-op
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Anesthesiology and Perioperative Medicine
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Peter A Nagi, MD
role: PRINCIPAL_INVESTIGATOR
References: