ColonoscopyPhase 4NCT03139279
Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy
A Phase 4 study testing Dexmedetomidine and Propofol in people with Colonoscopy, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial summary
An ideal sedative for colonoscopy should have properties that include: rapid onset and offset of action, provide cardiopulmonary stability, have minimal adverse effects, and allow for smooth recovery, and early discharge. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 19 Jul 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo colonoscopy at SUNY Downstate Medical Center.
Who cannot join
- < 18 years old
- > 75 years old
- Cognitively Impaired patients (Cognitively impaired patients are excluded from the study because our primary outcome involves a very strict discharge criteria that requires the patient to respond to and perform tasks on our pre-existing discharge scale checklist. These may be impossible to assess or will be difficult to standardize for patients whom are Cognitively Impaired.)
- Pregnant patients
- Patients who use a wheelchair or ambulates with crutches (Patients using a wheelchair are excluded from the study because our primary outcome involves a very strict discharge criteria that requires the patient to respond to and perform tasks on our pre-existing discharge scale checklist. These may be impossible to assess or will be difficult to standardize for patients whom who use a wheel-chair).
- Limited exercise tolerance (as this could represent active coronary disease)
Show all 11Show fewer
- Total body weight greater than 105 kg (due to maximal dose of drug available in randomized syringes containing study drug)
- Propofol, soy, glycerol or dexmedetomidine allergy
- Significant renal impairment
- Significant hepatic impairment
- Inability to read or write in English
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Medical Center
Brooklyn, New York, 11203
About this study
Official title: Comparing Time to Readiness for Discharge After Colonoscopy: Propofol and Dexmedetomidine vs Propofol Only Sedation
An ideal sedative for colonoscopy should have properties that include: rapid onset and offset of action, provide cardiopulmonary stability, have minimal adverse effects, and allow for smooth recovery, and early discharge. Propofol is often used solely because of its rapid onset and short duration of action---a property which is ideal for a fast recovery and early discharge in the ambulatory setting. However, the use of propofol has been associated with undesirable effects such as hypotension, hypoventilation and apnea requiring assisted ventilation.
Balanced anesthesia, using a combination of medications with different mechanisms of action can reduce the total amount of each sedative agent used and minimize their side effects while achieving the desired level of sedation. Dexmedetomidine is one agent that has been used either alone or in combination with propofol for sedation during colonoscopy. While there are many advantages to using dexmedetomidine, there is concern that the use of this agent for sedation during colonoscopy may prolong post-operative recovery time and readiness for discharge home.
No study has definitively assessed whether the use of dexmedetomidine in combination with propofol during ambulatory colonoscopy prolongs post-operative recovery time as determined by the Modified Post Anesthesia Discharge Scoring System (MPADSS).
Read the detailed description
In this study, investigators plan to prospectively compare in a randomized, controlled, double-blind trial, the sedation technique for colonoscopy between two groups. Group 1: sedation with dexmedetomidine and propopfol versus group 2: sedation with saline placebo and propofol.
The study will have the following outcome measures for each group.
Primary outcome measure:
Readiness-for-discharge (RFD) at 10, 20 and 30 minutes after the colonoscopic procedure. Ready-for-discharge is defined as attainment of MPADSS score of 9-10.
Secondary outcome measures:
- Total propofol consumption in mg/kg/duration of procedure in minutes;
- Side effects:
- lowest intraoperative percent (%) drop in mean arterial pressure (MAP) from baseline,
- incidence of sustained bradycardic episodes (HR<50 for at least 5 minutes) intraoperatively,
- incidence of apneic episodes intraoperatively requiring positive pressure ventilation.
Methods:
One hundred patients will be recruited and randomized into two groups. For sedation, Group 1 will receive intravenous dexmedetomidine 0.3 ug/kg bolused at the onset of the procedure followed by titrated doses of propofol. Group 2 will receive a saline placebo bolus at the onset of the procedure followed by titrated doses of propofol. A hospital research pharmacist, based on a randomization table, will allocate to the anesthesia provider giving the sedation, the bolus syringe labelled dexmedetomidine/or saline study agent. The anesthesia provider, gastroenterologist, nurses as well as the subject will be blinded as to the syringe's actual content. A Bispectral Index (BIS) Monitor will be used during sedation. All subjects will be targeted to maintain a BIS score between 60-70. Outcome measures will be evaluated for statistical significance in a non-inferiority assessment.
Investigators hypothesize that there will be no difference in the time to discharge between the two treatment groups.
- Conditions
- Colonoscopy
- Being tested
- Dexmedetomidine, Saline placebo, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dex, Precedex
Dexmedetomidine 0.3 ug/kg intravenous bolus
Saline placeboOther
Intravenous saline/placebo
PropofolDrug
Also called Diprivan
Propofol titrated intravenous boluses
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine and propofol | Experimental | Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70. Receives: Drug: Dexmedetomidine; Drug: Propofol |
| Saline placebo and propofol | Placebo comparator | Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70. Receives: Other: Saline placebo; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure
Each subject was assessed for readiness for discharge at 10, 20 and 30 minutes after the procedure, using the Modified Post-Anesthesia Discharge Scoring System (MPADSS). A subject getting an MPADS score of 9-10 is deemed ready for discharge. The percentage of subjects ready for discharge in each group at 10, 20 and 30 minutes will be measured as primary outcome.
Measured: 30 minutes
Secondary outcomes (4)
Average Total Propofol Consumption Per Group
Total propofol consumption per subject was measured as μg/kg/min of procedure in minutes. The average propofol consumption in each group will be measured as secondary outcome.
Measured: between 7 and 57 minutes (median 19 min)
Number of Participants With Sustained Bradycardic Episodes
Incidence of sustained bradycardic episodes (HR<50 for at least 5 minutes) intraoperatively in each group
Measured: 30 minutes
Lowest Intraoperative % Change in MAP From Baseline
Lowest intraoperative percent (%) change in mean arterial pressure (MAP) from baseline (average in each group)
Measured: 30 minutes
Number of Participants With Apneic Episodes Intraoperatively Requiring Positive Pressure Ventilation
Incidence of apneic episodes intraoperatively requiring positive pressure ventilation in each group
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start5 May 2017
- Primary completion4 May 2018
- Study completion19 Jul 2018
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 (12)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Dimaculangan, State University of New York - Downstate Medical Center
- Investigators
- Dennis Dimaculangan, MD, Principal investigator, SUNY Downstate Medical Center Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139279
- Sponsor's protocol ID
- IRB: 932304
- Status last verified
- Jul 2019
- First submitted
- 24 Apr 2017
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vicari JJ. Sedation and analgesia. Gastrointest Endosc Clin N Am. 2002 Apr;12(2):297-311, viii. doi: 10.1016/s1052-5157(01)00011-3.
PubMed 12180162Faigel DO, Baron TH, Goldstein JL, Hirota WK, Jacobson BC, Johanson JF, Leighton JA, Mallery JS, Peterson KA, Waring JP, Fanelli RD, Wheeler-Harbaugh J; Standards Practice Committe, American Society for Gastrointestinal Endoscopy. Guidelines for the use of deep sedation and anesthesia for GI endoscopy. Gastrointest Endosc. 2002 Nov;56(5):613-7. doi: 10.1016/s0016-5107(02)70104-1. No abstract available.
PubMed 12397263Waring JP, Baron TH, Hirota WK, Goldstein JL, Jacobson BC, Leighton JA, Mallery JS, Faigel DO; American Society for Gastrointestinal Endoscopy, Standards of Practice Committee. Guidelines for conscious sedation and monitoring during gastrointestinal endoscopy. Gastrointest Endosc. 2003 Sep;58(3):317-22. doi: 10.1067/s0016-5107(03)00001-4.
PubMed 14528201Akarsu Ayazoglu T, Polat E, Bolat C, Yasar NF, Duman U, Akbulut S, Yol S. Comparison of propofol-based sedation regimens administered during colonoscopy. Rev Med Chil. 2013 Apr;141(4):477-85. doi: 10.4067/S0034-98872013000400009.
PubMed 23900369Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20.
PubMed 25801162Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.
PubMed 11046225Taittonen MT, Kirvela OA, Aantaa R, Kanto JH. Effect of clonidine and dexmedetomidine premedication on perioperative oxygen consumption and haemodynamic state. Br J Anaesth. 1997 Apr;78(4):400-6. doi: 10.1093/bja/78.4.400.
PubMed 9135361Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042.
PubMed 12145072Jalowiecki P, Rudner R, Gonciarz M, Kawecki P, Petelenz M, Dziurdzik P. Sole use of dexmedetomidine has limited utility for conscious sedation during outpatient colonoscopy. Anesthesiology. 2005 Aug;103(2):269-73. doi: 10.1097/00000542-200508000-00009.
PubMed 16052108Dere K, Sucullu I, Budak ET, Yeyen S, Filiz AI, Ozkan S, Dagli G. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol. 2010 Jul;27(7):648-52. doi: 10.1097/EJA.0b013e3283347bfe.
PubMed 20531094Palumbo P, Tellan G, Perotti B, Pacile MA, Vietri F, Illuminati G. Modified PADSS (Post Anaesthetic Discharge Scoring System) for monitoring outpatients discharge. Ann Ital Chir. 2013 Nov-Dec;84(6):661-5.
PubMed 23165318Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
PubMed 5534693
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Time to Readiness for Discharge After Colonoscopy: Propofol and Dexmedetomidine vs Propofol Only Sedation
- ClinicalTrials.gov ID
- NCT03139279
- Acronym / sponsor ID
- IRB: 932304
- Conditions
- Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An ideal sedative for colonoscopy should have properties that include: rapid onset and offset of action, provide cardiopulmonary stability, have minimal adverse effects, and allow for smooth recovery, and early discharge. Propofol is often used solely because of its rapid onset and short duration of action---a property which is ideal for a fast recovery and early discharge in the ambulatory setting. However, the use of propofol has been associated with undesirable effects such as hypotension, hypoventilation and apnea requiring assisted ventilation.
Balanced anesthesia, using a combination of medications with different mechanisms of action can reduce the total amount of each sedative agent used and minimize their side effects while achieving the desired level of sedation. Dexmedetomidine is one agent that has been used either alone or in combination with propofol for sedation during colonoscopy. While there are many advantages to using dexmedetomidine, there is concern that the use of this agent for sedation during colonoscopy may prolong post-operative recovery time and readiness for discharge home.
No study has definitively assessed whether the use of dexmedetomidine in combination with propofol during ambulatory colonoscopy prolongs post-operative recovery time as determined by the Modified Post Anesthesia Discharge Scoring System (MPADSS).
Detailed description
In this study, investigators plan to prospectively compare in a randomized, controlled, double-blind trial, the sedation technique for colonoscopy between two groups. Group 1: sedation with dexmedetomidine and propopfol versus group 2: sedation with saline placebo and propofol.
The study will have the following outcome measures for each group.
Primary outcome measure:
Readiness-for-discharge (RFD) at 10, 20 and 30 minutes after the colonoscopic procedure. Ready-for-discharge is defined as attainment of MPADSS score of 9-10.
Secondary outcome measures:
- Total propofol consumption in mg/kg/duration of procedure in minutes;
- Side effects:
- lowest intraoperative percent (%) drop in mean arterial pressure (MAP) from baseline,
- incidence of sustained bradycardic episodes (HR<50 for at least 5 minutes) intraoperatively,
- incidence of apneic episodes intraoperatively requiring positive pressure ventilation.
Methods:
One hundred patients will be recruited and randomized into two groups. For sedation, Group 1 will receive intravenous dexmedetomidine 0.3 ug/kg bolused at the onset of the procedure followed by titrated doses of propofol. Group 2 will receive a saline placebo bolus at the onset of the procedure followed by titrated doses of propofol. A hospital research pharmacist, based on a randomization table, will allocate to the anesthesia provider giving the sedation, the bolus syringe labelled dexmedetomidine/or saline study agent. The anesthesia provider, gastroenterologist, nurses as well as the subject will be blinded as to the syringe's actual content. A Bispectral Index (BIS) Monitor will be used during sedation. All subjects will be targeted to maintain a BIS score between 60-70. Outcome measures will be evaluated for statistical significance in a non-inferiority assessment.
Investigators hypothesize that there will be no difference in the time to discharge between the two treatment groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine and propofol | Experimental | Drug: Dexmedetomidine, Drug: PropofolIntravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70. |
| Saline placebo and propofol | Placebo comparator | Other: Saline placebo, Drug: PropofolIntravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to undergo colonoscopy at SUNY Downstate Medical Center.
Key exclusion criteria (11 listed)
- < 18 years old
- > 75 years old
- Cognitively Impaired patients (Cognitively impaired patients are excluded from the study because our primary outcome involves a very strict discharge criteria that requires the patient to respond to and perform tasks on our pre-existing discharge scale checklist. These may be impossible to assess or will be difficult to standardize for patients whom are Cognitively Impaired.)
- Pregnant patients
- Patients who use a wheelchair or ambulates with crutches (Patients using a wheelchair are excluded from the study because our primary outcome involves a very strict discharge criteria that requires the patient to respond to and perform tasks on our pre-existing discharge scale checklist. These may be impossible to assess or will be difficult to standardize for patients whom who use a wheel-chair).
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 |
|---|---|---|
| DexmedetomidineAlso: Dex, PrecedexDexmedetomidine 0.3 ug/kg intravenous bolus | Drug | Dexmedetomidine and propofol |
| Saline placeboIntravenous saline/placebo | Other | Saline placebo and propofol |
| PropofolAlso: DiprivanPropofol titrated intravenous boluses | Drug | Dexmedetomidine and propofol, Saline placebo and propofol |
Primary outcome
Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure
Time frame: 30 minutes
Each subject was assessed for readiness for discharge at 10, 20 and 30 minutes after the procedure, using the Modified Post-Anesthesia Discharge Scoring System (MPADSS). A subject getting an MPADS score of 9-10 is deemed ready for discharge. The percentage of subjects ready for discharge in each group at 10, 20 and 30 minutes will be measured as primary outcome.
4 secondary outcomes
Average Total Propofol Consumption Per Group
Time frame: between 7 and 57 minutes (median 19 min)
Number of Participants With Sustained Bradycardic Episodes
Time frame: 30 minutes
Lowest Intraoperative % Change in MAP From Baseline
Time frame: 30 minutes
Number of Participants With Apneic Episodes Intraoperatively Requiring Positive Pressure Ventilation
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12180162Vicari JJ. Sedation and analgesia. Gastrointest Endosc Clin N Am. 2002 Apr;12(2):297-311, viii. doi: 10.1016/s1052-5157(01)00011-3.
- Background: PubMed 12397263Faigel DO, Baron TH, Goldstein JL, Hirota WK, Jacobson BC, Johanson JF, Leighton JA, Mallery JS, Peterson KA, Waring JP, Fanelli RD, Wheeler-Harbaugh J; Standards Practice Committe, American Society for Gastrointestinal Endoscopy. Guidelines for the use of deep sedation and anesthesia for GI endoscopy. Gastrointest Endosc. 2002 Nov;56(5):613-7. doi: 10.1016/s0016-5107(02)70104-1. No abstract available.
- Background: PubMed 14528201Waring JP, Baron TH, Hirota WK, Goldstein JL, Jacobson BC, Leighton JA, Mallery JS, Faigel DO; American Society for Gastrointestinal Endoscopy, Standards of Practice Committee. Guidelines for conscious sedation and monitoring during gastrointestinal endoscopy. Gastrointest Endosc. 2003 Sep;58(3):317-22. doi: 10.1067/s0016-5107(03)00001-4.
- Background: PubMed 23900369Akarsu Ayazoglu T, Polat E, Bolat C, Yasar NF, Duman U, Akbulut S, Yol S. Comparison of propofol-based sedation regimens administered during colonoscopy. Rev Med Chil. 2013 Apr;141(4):477-85. doi: 10.4067/S0034-98872013000400009.
- Background: PubMed 25801162Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20.
- Background: PubMed 11046225Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.
- Background: PubMed 9135361Taittonen MT, Kirvela OA, Aantaa R, Kanto JH. Effect of clonidine and dexmedetomidine premedication on perioperative oxygen consumption and haemodynamic state. Br J Anaesth. 1997 Apr;78(4):400-6. doi: 10.1093/bja/78.4.400.
- Background: PubMed 12145072Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042.
- Background: PubMed 16052108Jalowiecki P, Rudner R, Gonciarz M, Kawecki P, Petelenz M, Dziurdzik P. Sole use of dexmedetomidine has limited utility for conscious sedation during outpatient colonoscopy. Anesthesiology. 2005 Aug;103(2):269-73. doi: 10.1097/00000542-200508000-00009.
- Background: PubMed 20531094Dere K, Sucullu I, Budak ET, Yeyen S, Filiz AI, Ozkan S, Dagli G. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol. 2010 Jul;27(7):648-52. doi: 10.1097/EJA.0b013e3283347bfe.
- Background: PubMed 23165318Palumbo P, Tellan G, Perotti B, Pacile MA, Vietri F, Illuminati G. Modified PADSS (Post Anaesthetic Discharge Scoring System) for monitoring outpatients discharge. Ann Ital Chir. 2013 Nov-Dec;84(6):661-5.
- Background: PubMed 5534693Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
- 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.
Dennis Dimaculangan, MD principal investigator
SUNY Downstate Medical Center Department of Anesthesiology
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 and Propofol in people with Colonoscopy, run by State University of New York - Downstate Medical Center 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 11 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 29 Jul 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 16 Jul 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?
Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure (time frame: 30 minutes). 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 NCT03139279, which also lists 12 linked publications.
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 29 Jul 2019.