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NCT01535976 · ClinicalTrials.gov registry record · NA
Ketamine Infusion and Hypoventilation
A NA study of Hypoventilation, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT01535976 is a NA study of Hypoventilation that has completed, run by Northwestern University. The registered enrollment target is 54 participants, roughly in line with the 50-participant average among 3 other Hypoventilation trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT01535976, a NA study of Hypoventilation, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study 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 pa
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ketamine
Study Locations (1)
Illinois
- Prentice Womens Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01535976
The ClinicalTrials.gov registry entry for NCT01535976 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 50-participant average among 3 other Hypoventilation trials with a reported enrollment target. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypoventilation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01535976 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01535976 about?
NCT01535976 is a clinical study titled "Ketamine Infusion and Hypoventilation". 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 ...
What is the current status of trial NCT01535976?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2011-08. Estimated completion is 2013-05.
What conditions does trial NCT01535976 study?
This clinical trial studies the following conditions: Hypoventilation.
What interventions are being tested in trial NCT01535976?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG).
Who is sponsoring clinical trial NCT01535976?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01535976 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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