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

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

Detailed Description
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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.

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

Conditions
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Sleep Apnea, Obstructive Sleep Apnea, Postoperative Complications

Intervention / Treatment
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* Drug: Ketamine
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>OSA patients will receive standard inhaled anesthesia with normal saline infusion | Procedure: Control<br>* OSA patients receiving standard inhaled anesthesia combined with normal saline<br>|
| Active Comparator: Ketamine Group<br>OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion. | Drug: Ketamine<br>* OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight<br>* Other names: Ketalar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Visual Analog Scale pain rating | up to 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Score | Patients will rate their quality of anesthesia services | At 24 hrs post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Postoperative morbidity