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WithdrawnNCT01825083Updated May 8, 2014

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

An interventional study of Ketamine and Placebo in Hypercarbia, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-05-08.

Sponsored by Northwestern University · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Change in personnel
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Female
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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 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.

02

Conditions studied

  • Hypercarbia

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Keywords

  • Hypercarbia
  • TOSCA monitor
  • Ketamine
  • Fentanyl
  • Intraoperative monitoring
03

In context

Hypercapnia

191 studies on the registry are indexed under Hypercapnia; 36 are open to participants now.

Browse Hypercapnia studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

ASA I and II

  • Age 18-64
  • Females undergoing sedation procedures

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Ketamine

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

    Drug: Ketamine

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • Ketamine group receives 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.

    Also known as: Ketamine adminstration

  • DrugPlacebo

    0.9 % normal saline group receives same volume as the ketamine dose

    Also known as: 0.9 % normal saline group receives same volume as ketamine dose

06

What researchers measure

Primary outcomes

  1. The total percentage time patients hypoventilate during the case

    The total percentage time patients hypoventilate during the case

    Time frame: Day 1

07

Study locations

1 site
  • Prentice Womens Hospital
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01825083
Responsible party
Gildasio De Oliveira (Prinipal Investigator, Northwestern University) — Principal investigator
First posted
Apr 5, 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
May 8, 2014

Study contacts

Gildasio De Oliveira, MD,MS
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ketamine

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