The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl
Public ClinicalTrials.gov record NCT01825083. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01825083
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Feb 28, 2014
- Completion
- Feb 28, 2014
- Last update posted
- May 7, 2014
Ends 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Prentice Womens Hospital | Chicago | Illinois | 60611 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01825083, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2014 · Synced Sep 11, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01825083 live on ClinicalTrials.gov.