Sleep ApneaPhase 2/3NCT03109418
Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
A Phase 2/3 study testing Ketamine in people with Sleep Apnea and Obstructive Sleep Apnea, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive Sleep Apnea, Postoperative Complications
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2016to 12 Sep 2018
- Phase
- Phase 2/3
- 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 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 19-100
- scheduled to undergo general ENT or Orthopedic Surgery
- diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).
Who cannot join
- positive pregnancy test
- ASA > III
- history of alcohol or narcotic abuse in last 90 days
- significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%)
- significant psychiatric or neurologic disease
- history of significant hepatic or renal disease (baseline creatinine>1.5)
Show all 18Show fewer
- history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP
- increased IOP
- severe arrhythmias
- history of delirium
- history of hallucinations
- history of psychosis
- history of uncontrolled seizures
- potential risk for malignant hyperthermia (family history)
- history of difficult intubation that would preclude standard induction of anesthesia
- prisoners
- persons who are mentally impaired
- non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, 35249
About this study
Official title: Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.
Read the detailed description
Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.
- Being tested
- Ketamine, Control
- Keywords
- Ketamine, Postoperative morbidity
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight
ControlProcedure or surgery
OSA patients receiving standard inhaled anesthesia combined with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | OSA patients will receive standard inhaled anesthesia with normal saline infusion Receives: Procedure: Control |
| Ketamine Group | Active comparator | OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Visual Analog Scale pain rating
Measured: up to 24 hours postoperatively
Secondary outcomes (1)
Patient Satisfaction Score
Patients will rate their quality of anesthesia services
Measured: At 24 hrs post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start2 Jun 2016
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Why it stopped: Recruitment challenges
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.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter A. Nagi, University of Alabama at Birmingham
- Investigators
- Peter A Nagi, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109418
- Sponsor's protocol ID
- F160224001
- Status last verified
- Dec 2019
- First submitted
- 6 Apr 2017
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT03109418
- Acronym / sponsor ID
- F160224001
- Keywords
- Ketamine, Postoperative morbidity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.
Detailed description
Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Procedure: ControlOSA patients will receive standard inhaled anesthesia with normal saline infusion |
| Ketamine Group | Active comparator | Drug: KetamineOSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 19-100
- scheduled to undergo general ENT or Orthopedic Surgery
- diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).
Key exclusion criteria (18 listed)
- positive pregnancy test
- ASA > III
- history of alcohol or narcotic abuse in last 90 days
- significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%)
- significant psychiatric or neurologic disease
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 |
|---|---|---|
| KetamineAlso: KetalarOSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight | Drug | Ketamine Group |
| ControlOSA patients receiving standard inhaled anesthesia combined with normal saline | Procedure or surgery | Control Group |
Primary outcome
Pain Scores
Time frame: up to 24 hours postoperatively
Visual Analog Scale pain rating
1 secondary outcome
Patient Satisfaction Score
Time frame: At 24 hrs post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Peter A Nagi, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine in people with Sleep Apnea and Obstructive Sleep Apnea, run by University of Alabama at Birmingham 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 18 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: stopped early, as of the sponsor's last update on 19 Dec 2019. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2019). 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?
Pain Scores (time frame: up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2019; AzTrials last refreshed its copy on 2 Nov 2026.