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Ketamine Infusion and Hypoventilation

Primary Purpose

Hypoventilation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Ketamine
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoventilation

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Prentice Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Ketamine

Arm Description

.9 normal saline infusion

Infusion of ketamine

Outcomes

Primary Outcome Measures

Intraoperative Hypoventilation
Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2011
Last Updated
February 18, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01535976
Brief Title
Ketamine Infusion and Hypoventilation
Official Title
The Effect of Ketamine in The Prevention of Hypoventilation in Patients With and Without a Positive Berlin Questionnaire Undergoing Deep Sedation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoventilation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
.9 normal saline infusion
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Infusion of ketamine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator: Placebo .9 normal saline infusion
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case
Primary Outcome Measure Information:
Title
Intraoperative Hypoventilation
Description
Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.
Time Frame
8 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gildasio De Oliveira, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prentice Womens Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24247410
Citation
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.
Results Reference
derived

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Ketamine Infusion and Hypoventilation

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