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

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ClinicalTrials.gov Identifier: NCT03109418
Recruitment Status : Terminated (Recruitment challenges)
First Posted : April 12, 2017
Results First Posted : December 19, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Peter A. Nagi, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 12, 2017
Results First Submitted Date  ICMJE October 1, 2019
Results First Posted Date  ICMJE December 19, 2019
Last Update Posted Date December 19, 2019
Actual Study Start Date  ICMJE June 2, 2016
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
Pain Scores [ Time Frame: up to 24 hours postoperatively ]
Visual Analog Scale pain rating
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Time to first analgesic [ Time Frame: Baseline to 48 hrs postoperatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
Patient Satisfaction Score [ Time Frame: At 24 hrs post-op ]
Patients will rate their quality of anesthesia services
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Comparison of Patient Demographics [ Time Frame: Baseline to 48 hrs postoperatively ]
    Vital signs
  • Mean number of analgesic (PCA) demands [ Time Frame: Baseline to 48 hrs postoperatively ]
    Total number of PCA demands during the initial 24 hour postoperative period
  • Mean amount of analgesic consumed in the OR and PACU [ Time Frame: Baseline to 48 hrs postoperatively ]
    Total amount of morphine administered by PCA during the initial 24 hour postoperative period
  • Frequency of side events [ Time Frame: Baseline to 48 hrs postoperatively ]
    Side events includes adverse respiratory event, hemodynamic instability, presence of nausea, presence of vomiting, presence dysphoria, and admission to the ICU
  • Mean number of desaturations [ Time Frame: Baseline to 48 hrs postoperatively ]
    The oxygen desaturation index (ODI) or the number of desaturations per hour of recording will be collected. ODI correlates with PSG-determined apnea/hypopnea idex and can be used as an indicator of postoperative apneic episodes.
  • Patient Satisfaction Score [ Time Frame: At 24 hrs post-op ]
    Patients will rate their quality of anesthesia services
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
Official Title  ICMJE Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Sleep Apnea
  • Obstructive Sleep Apnea
  • Postoperative Complications
Intervention  ICMJE
  • Drug: Ketamine
    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
    Other Name: Ketalar
  • Procedure: Control
    OSA patients receiving standard inhaled anesthesia combined with normal saline
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    OSA patients will receive standard inhaled anesthesia with normal saline infusion
    Intervention: Procedure: Control
  • Active Comparator: Ketamine Group
    OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 14, 2018)
9
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
150
Actual Study Completion Date  ICMJE September 12, 2018
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03109418
Other Study ID Numbers  ICMJE F160224001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peter A. Nagi, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter A Nagi, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP