HypoventilationNCT01535976
Ketamine Infusion and Hypoventilation
A study testing Ketamine in people with Hypoventilation, run by Northwestern University at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Hypoventilation
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I,II
- Age 18-64
- Females undergoing surgical procedures requiring sedation
Who cannot join
- Pregnant subjects
- Breastfeeding
- Patients or surgeon request
- ---Drop Out:
- Patient or surgeon request,
- Conversion to general anesthesia
- Inability to obtain data from Co2 monitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ketamine in The Prevention of Hypoventilation in Patients With and Without a Positive Berlin Questionnaire Undergoing Deep Sedation
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.
Read more
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.
- Conditions
- Hypoventilation
- Being tested
- Placebo, Ketamine
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo Comparator: Placebo
.9 normal saline infusion
KetamineDrug
Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | .9 normal saline infusion Receives: Drug: Placebo |
| Ketamine | Active comparator | Infusion of ketamine Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Hypoventilation
Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoventilationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gildasio De Oliveira, Northwestern University
- Investigators
- Gildasio De Oliveira, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535976
- Sponsor's protocol ID
- STU00048723
- Status last verified
- Feb 2014
- First submitted
- 9 Sep 2011
- Last updated
- 1 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24247410
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketamine in The Prevention of Hypoventilation in Patients With and Without a Positive Berlin Questionnaire Undergoing Deep Sedation
- ClinicalTrials.gov ID
- NCT01535976
- Acronym / sponsor ID
- STU00048723
- Conditions
- Hypoventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo.9 normal saline infusion |
| Ketamine | Active comparator | Drug: KetamineInfusion of ketamine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I,II
- Age 18-64
- Females undergoing surgical procedures requiring sedation
Key exclusion criteria (7 listed)
- Pregnant subjects
- Breastfeeding
- Patients or surgeon request
- Patient or surgeon request,
- Conversion to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo Comparator: Placebo .9 normal saline infusion | Drug | Placebo |
| KetamineKetamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case | Drug | Ketamine |
Primary outcome
Intraoperative Hypoventilation
Time frame: 8 hours
Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24247410De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gildasio De Oliveira, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Hypoventilation, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Hypoventilation (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01535976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.