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

Primary Purpose

Hypercarbia

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Withdrawn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

About this trial

This is an interventional prevention trial for Hypercarbia focused on measuring Hypercarbia, TOSCA monitor, Ketamine, Fentanyl, Intraoperative monitoring

Eligibility Criteria

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

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.

Sites / Locations

  • Prentice Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine

Placebo

Arm Description

Ketamine administered 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.

Saline group will received the same volume in saline as the ketamine dose

Outcomes

Primary Outcome Measures

The total percentage time patients hypoventilate during the case
The total percentage time patients hypoventilate during the case

Secondary Outcome Measures

Full Information

First Posted
January 31, 2013
Last Updated
May 7, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01825083
Brief Title
The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl
Official Title
The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Change in personnel
Study Start Date
undefined (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercarbia
Keywords
Hypercarbia, TOSCA monitor, Ketamine, Fentanyl, Intraoperative monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Ketamine administered 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline group will received the same volume in saline as the ketamine dose
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine adminstration
Intervention Description
Ketamine group receives 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9 % normal saline group receives same volume as ketamine dose
Intervention Description
0.9 % normal saline group receives same volume as the ketamine dose
Primary Outcome Measure Information:
Title
The total percentage time patients hypoventilate during the case
Description
The total percentage time patients hypoventilate during the case
Time Frame
Day 1

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gildasio De Oliveira, MD,MS
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

Learn more about this trial

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

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