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

Ketamine

Brief Summary

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

Intervention / Treatment

  • Ketamine (DRUG)
    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
  • Control (PROCEDURE)
    OSA patients receiving standard inhaled anesthesia combined with normal saline

Condition or Disease

  • Sleep Apnea
  • Obstructive Sleep Apnea
  • Postoperative Complications

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 19 Years to 100 Years
    Enrollment: 9 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jun 02, 2016 ACTUAL
    Primary Completion: Sep 12, 2018 ACTUAL
    Completion Date: Sep 12, 2018 ACTUAL
    Study First Posted: Apr 12, 2017 ACTUAL
    Results First Posted: Dec 19, 2019 ACTUAL
    Last Updated: Dec 18, 2019

    Sponsors / Collaborators

    Lead Sponsor: University of Alabama at Birmingham
    Responsible Party: N/A

    Location

    Birmingham, Alabama, USA

    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.

    Participant Groups

    • OSA patients will receive standard inhaled anesthesia with normal saline infusion

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 19
    Maximum Age: 100
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    • Visual Analog Scale pain rating

    Secondary Outcomes

    • Patients will rate their quality of anesthesia services

    More Details

    NCT Number: NCT03109418
    Other IDs: F160224001
    Study URL: https://clinicaltrials.gov/study/NCT03109418
    Last updated: Sep 29, 2023