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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Postoperative Complications; Sleep Apnea; Obstructive Sleep Apnea

Treatments: Drug: Ketamine; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03109418

F160224001

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 19 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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9 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

OSA patients will receive standard inhaled anesthesia with normal saline infusion

Treatment:

Procedure: Control

Ketamine Group

Active Comparator group

Description:

OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.

Treatment:

Drug: Ketamine