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Ketamine Infusion and Hypoventilation

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ClinicalTrials.gov Identifier: NCT01535976
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : April 1, 2014
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Tracking Information
First Submitted Date  ICMJE September 9, 2011
First Posted Date  ICMJE February 20, 2012
Results First Submitted Date  ICMJE November 11, 2013
Results First Posted Date  ICMJE April 1, 2014
Last Update Posted Date April 1, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
Intraoperative Hypoventilation [ Time Frame: 8 hours ]
Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
Decreased intraoperative hypoventilation [ Time Frame: 8 hours ]
Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusion and Hypoventilation
Official Title  ICMJE The Effect of Ketamine in The Prevention of Hypoventilation in Patients With and Without a Positive Berlin Questionnaire Undergoing Deep Sedation
Brief Summary

Procedures performed under sedation have the same severity in regards to morbidity and mortality as procedures performed under general anesthesia1. The demand for anesthesia care outside the operating room has increased tremendously and it poses, according to a closed claim analysis, major risks to patients . Both closed claim analysis identified respiratory depression due to oversedation as the main risk to patients undergoing procedures under sedation. The major problem is that hypoventilation is only detected at very late stages in patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation, hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.

The incidence of anesthetized patients with obstructive sleep apnea has increased substantially over the last years along with the current national obesity epidemic. These patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The context of the massive increase in procedural sedation and the extremely high prevalence of obstructive sleep apnea poses major respiratory risks to patients and it may, in a near future, increase malpractice claims to anesthesiologists. The development of safer anesthesia regimen for sedation are, therefore, needed. The establishment of safer anesthetics regimen for sedation is in direct relationship with the anesthesia patient safety foundation priorities. It addresses peri-anesthetic safety problems for healthy patient's. It can also be broadly applicable and easily implemented into daily clinical care.

Ketamine has an established effect on analgesia but the effects of ketamine on ventilation have not been clearly defined. The lack of validated and sensitive instruments to evaluate the effects of ketamine on ventilation is an important reason for the conflicting results.The investigators have demonstrated that the transcutaneous carbon dioxide monitor is accurate in detecting hypoventilation in patients undergoing deep sedation. Animal data suggest that when added to propofol in a sedation regimen, ketamine decreased hypoventilation when compared to propofol alone. It is unknown if ketamine added to a commonly used sedative agent (propofol) can decrease the incidence and severity of hypoventilation in patients undergoing deep sedation. It is also unknown if the effect of ketamine on ventilation are different in patients with and without obstructive sleep apnea.

The investigators hypothesized that patients receiving ketamine and propofol will develop less intraoperative hypoventilation than patients receiving propofol alone. The investigators also hypothesized that this effect will be even greater in patients with obstructive sleep apnea than patients without obstructive sleep apnea.

Significance: Respiratory depression due to oversedation was identified twice as the major factor responsible for claims related to anesthesia. The high prevalence of obstructive sleep apnea combined with more complex procedures done in outpatient settings can increase physical risks to patients and liability cases to anesthesiologists. The main goal of this project is to establish the effect of ketamine in preventing respiratory depression to patients undergoing procedures under sedation. If the investigators confirm the their hypothesis , their findings can be valuable not only to anesthesiologist but also to other specialties ( Emergency medicine, gastroenterologists, cardiologists, radiologists) that frequently performed procedural sedation. The research questions is;does ketamine prevent hypoventilation during deep sedation? The hypotheses is; ketamine will prevent hypoventilation during sedation cases.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hypoventilation
Intervention  ICMJE
  • Drug: Placebo

    Placebo Comparator: Placebo

    .9 normal saline infusion

  • Drug: Ketamine
    Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    .9 normal saline infusion
    Intervention: Drug: Placebo
  • Active Comparator: Ketamine
    Infusion of ketamine
    Intervention: Drug: Ketamine
Publications * De Oliveira GS Jr, Fitzgerald PC, Hansen N, Ahmad S, McCarthy RJ. The effect of ketamine on hypoventilation during deep sedation with midazolam and propofol: a randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2014 Dec;31(12):654-62. doi: 10.1097/EJA.0000000000000025.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2013)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2012)
150
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I,II
  • Age 18-64
  • Females undergoing surgical procedures requiring sedation

Exclusion Criteria:

  • Pregnant subjects
  • Breastfeeding
  • Patients or surgeon request

    ---Drop Out:

  • Patient or surgeon request,
  • Conversion to general anesthesia
  • Inability to obtain data from Co2 monitor
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01535976
Other Study ID Numbers  ICMJE STU00048723
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gildasio De Oliveira, Northwestern University
Original Responsible Party Gildasio De Oliveria, Northwestern University, Gildasio De Oliveira, M.D. Principal Investigator
Current Study Sponsor  ICMJE Northwestern University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gildasio De Oliveira, MD Northwestern University
PRS Account Northwestern University
Verification Date February 2014

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