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

• Status: Terminated
• Trial end date: 2018-09-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Anesthetics; Ketamine

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