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The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl

This study has been withdrawn prior to enrollment.
(Change in personnel)
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01825083
First received: January 31, 2013
Last updated: May 7, 2014
Last verified: May 2014

January 31, 2013
May 7, 2014
Not Provided
March 2014   (final data collection date for primary outcome measure)
The total percentage time patients hypoventilate during the case [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
The total percentage time patients hypoventilate during the case
Same as current
Complete list of historical versions of study NCT01825083 on ClinicalTrials.gov Archive Site
Not Provided
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The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl
The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl

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 over sedation 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 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) and fentanyl can decrease the incidence and severity of hypoventilation in patients undergoing deep sedation.

The investigators hypothesize that patients receiving ketamine, propofol and fentanyl will develop less intraoperative hypoventilation than patients receiving propofol and fentanyl.

The investigators also hypothesize that this effect will be even greater in patients with obstructive sleep apnea than patients without obstructive sleep apnea.

Significance: Respiratory depression due to over sedation 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 deep sedation using propofol and fentanyl.

If the investigators can confirm our hypothesis, our 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 the addition of ketamine prevent hypoventilation during deep sedation using propofol and fentanyl?

The hypotheses of this study: Ketamine will prevent hypoventilation during deep sedation cases.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Hypercarbia
  • Drug: Ketamine
    Ketamine group receives 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.
    Other Name: Ketamine adminstration
  • Drug: Placebo
    0.9 % normal saline group receives same volume as the ketamine dose
    Other Name: 0.9 % normal saline group receives same volume as ketamine dose
  • Active Comparator: Ketamine
    Ketamine administered 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Saline group will received the same volume in saline as the ketamine dose
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

ASA I and II

  • Age 18-64
  • Females undergoing sedation procedures

Exclusion Criteria:

  • Pregnant subjects
  • Breastfeeding
  • Patients or surgeon request
  • Difficult airway

Drop Out:

  • Patient or surgeon request
  • Conversion to general anesthesia .Inability to obtain data from CO2 monitor.
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01825083
STU00068533
No
Gildasio De Oliveira, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Gildasio De Oliveira, MD,MS Northwestern University
Northwestern University
May 2014

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