SedationPhase 4DEXNCT01158820
Alternative Sedation During Bronchoscopy
A Phase 4 study testing Dexmedetomidine load, Ketamine load and Midazolam load in people with Sedation, run by University of Pennsylvania at 1 site in United States.
Trial summary
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sedation
- What is being tested?
- Dexmedetomidine load, Ketamine load and Midazolam load
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2012
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP
Who cannot join
- History of inability to complete bronchoscopy attributable to inadequate sedation
- Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%
- History of allergy to study medications
- Pregnancy
- A history of psychosis
- Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease
- Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist
- A diagnosis of significant renal or hepatic impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
Read the detailed description
All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.
- Conditions
- Sedation
- Being tested
- Dexmedetomidine load, Ketamine load, Midazolam load, Fentanyl load, Dexmedetomidine maintenance
- Keywords
- bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine loadDrug
Also called Precedex, Dexmedetomidine Hydrochloride
Dexmedetomidine 1 µg/kg prior to bronchoscopy
Ketamine loadDrug
Also called Ketalar, Calypsol, Ketamin, Ketaminol
Ketamine 30 mg bolus prior to bronchoscopy
Midazolam loadDrug
Also called Versed
2 mg bolus prior to bronchoscopy
Fentanyl loadDrug
Also called Abstral, Actiq, Fentora, Onsolis
50 µg bolus prior to bronchoscopy
Dexmedetomidine maintenanceDrug
Also called Precedex, Dexmedetomidine Hydrochloride
0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
Ketamine maintenanceDrug
Also called Ketalar, Calypsol, Ketamin, Ketaminol
8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
Midazolam demandDrug
Also called Versed
0.5 mg demand bolus at discretion of pulmonologist
Fentanyl demandDrug
Also called Abstral, Actiq, Fentora, Onsolis
12.5 µg demand bolus at discretion of pulmonologist
Benadryl demandDrug
Also called Diphenhydramine Hcl, Aler-Dryl, Banophen, Ben Tann
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand Receives: Drug: Midazolam load; Drug: Fentanyl load; Drug: Midazolam demand; Drug: Fentanyl demand; Drug: Benadryl demand |
| dexmedetomidine and ketamine | Active comparator | dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand Receives: Drug: Dexmedetomidine load; Drug: Ketamine load; Drug: Dexmedetomidine maintenance; Drug: Ketamine maintenance; Drug: Midazolam demand; Drug: Fentanyl demand; Drug: Benadryl demand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Minute Ventilation
An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.
Measured: During the bronchoscopy procedure only, 58.5 minutes average
Total Fentanyl
Total fentanyl dose delivered during the procedure
Measured: During the bronchoscopy procedure only, 58.5 minutes average
Total Midazolam
Total midazolam delivered during procedure
Measured: Duration of procedure
Secondary outcomes (5)
Desaturation (Cumulative)
Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%
Measured: During the bronchoscopy procedure only, 58.5 minutes average
Desaturation (Longest)
Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)
Measured: During the bronchoscopy procedure only, 58.5 minutes average
Conversion to General Anesthesia
Patients in which the procedure could not be completed without conversion to general anesthesia
Measured: During the bronchoscopy procedure only, 58.5 minutes average
Patient Satisfaction
Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
Measured: After the bronchoscopy procedure only
Endoscopist Satisfaction
Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
Measured: After the bronchoscopy procedure only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMay 2012
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 SedationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Jeff E Mandel, MD MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158820
- Sponsor's protocol ID
- 810981
- Acronym
- DEX
- Status last verified
- Feb 2019
- First submitted
- 25 Jun 2010
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yarmus LB, Akulian JA, Gilbert C, Mathai SC, Sathiyamoorthy S, Sahetya S, Harris K, Gillespie C, Haas A, Feller-Kopman D, Sterman D, Lee HJ. Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration. Ann Am Thorac Soc. 2013 Apr;10(2):121-6. doi: 10.1513/AnnalsATS.201209-074OC.
PubMed 23607840
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation
- ClinicalTrials.gov ID
- NCT01158820
- Acronym / sponsor ID
- DEX / 810981
- Conditions
- Sedation
- Keywords
- bronchoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 31 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
Detailed description
All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Midazolam load, Drug: Fentanyl load, Drug: Midazolam demand, Drug: Fentanyl demand, Drug: Benadryl demandmidazolam load fentanyl load midazolam demand fentanyl demand benadryl demand |
| dexmedetomidine and ketamine | Active comparator | Drug: Dexmedetomidine load, Drug: Ketamine load, Drug: Dexmedetomidine maintenance, Drug: Ketamine maintenance, Drug: Midazolam demand, Drug: Fentanyl demand, Drug: Benadryl demanddexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP
Key exclusion criteria (8 listed)
- History of inability to complete bronchoscopy attributable to inadequate sedation
- Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%
- History of allergy to study medications
- Pregnancy
- A history of psychosis
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 |
|---|---|---|
| Dexmedetomidine loadAlso: Precedex, Dexmedetomidine HydrochlorideDexmedetomidine 1 µg/kg prior to bronchoscopy | Drug | dexmedetomidine and ketamine |
| Ketamine loadAlso: Ketalar, Calypsol, Ketamin, KetaminolKetamine 30 mg bolus prior to bronchoscopy | Drug | dexmedetomidine and ketamine |
| Midazolam loadAlso: Versed2 mg bolus prior to bronchoscopy | Drug | Placebo |
| Fentanyl loadAlso: Abstral, Actiq, Fentora, Onsolis50 µg bolus prior to bronchoscopy | Drug | Placebo |
| Dexmedetomidine maintenanceAlso: Precedex, Dexmedetomidine Hydrochloride0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average) | Drug | dexmedetomidine and ketamine |
| Ketamine maintenanceAlso: Ketalar, Calypsol, Ketamin, Ketaminol8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average) | Drug | dexmedetomidine and ketamine |
| Midazolam demandAlso: Versed0.5 mg demand bolus at discretion of pulmonologist | Drug | Placebo, dexmedetomidine and ketamine |
| Fentanyl demandAlso: Abstral, Actiq, Fentora, Onsolis12.5 µg demand bolus at discretion of pulmonologist | Drug | Placebo, dexmedetomidine and ketamine |
| Benadryl demandAlso: Diphenhydramine Hcl, Aler-Dryl, Banophen, Ben Tann25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus | Drug | Placebo, dexmedetomidine and ketamine |
Primary outcome
Decreased Minute Ventilation
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.
Total Fentanyl
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
Total fentanyl dose delivered during the procedure
Total Midazolam
Time frame: Duration of procedure
Total midazolam delivered during procedure
5 secondary outcomes
Desaturation (Cumulative)
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
Desaturation (Longest)
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
Conversion to General Anesthesia
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
Patient Satisfaction
Time frame: After the bronchoscopy procedure only
Endoscopist Satisfaction
Time frame: After the bronchoscopy procedure only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23607840Yarmus LB, Akulian JA, Gilbert C, Mathai SC, Sathiyamoorthy S, Sahetya S, Harris K, Gillespie C, Haas A, Feller-Kopman D, Sterman D, Lee HJ. Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration. Ann Am Thorac Soc. 2013 Apr;10(2):121-6. doi: 10.1513/AnnalsATS.201209-074OC.
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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.
Jeff E Mandel, MD MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine load, Ketamine load and Midazolam load in people with Sedation, run by University of Pennsylvania 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 1 inclusion and 8 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 26 Feb 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 31 Oct 2018). 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?
Decreased Minute Ventilation (time frame: During the bronchoscopy procedure only, 58.5 minutes average). The study lists 3 primary outcomes in all. 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 NCT01158820, 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 26 Feb 2019.