Procedural SedationPhase 4DexmedNCT02180737
Dexmedetomidine for Sedation During Radiological Interventional Procedures
A Phase 4 study testing Dexmeditomedine in people with Procedural Sedation, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Dexmeditomedine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18-65 years old
- ASA physical status of I-II
- Expected procedure lasting at least 30 minutes
Who cannot join
- Unstable cardiac status (life-threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction and third-degree heart block.
- An alpha2-agonist or antagonist within 14 days before the scheduled procedure.
- patients received an IV opioid within 1 h, or an oral or IM opioid within 4 h of the start of study drug administration.
- Patients who are allergic to Dexmedetomidine or alpha 2-agonists.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Role of Dexmedetomidine as a Sole Agent in Sedation of Cancer Patients Undergoing Radiological Interventional Procedures
Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.
- Conditions
- Procedural Sedation
- Being tested
- Dexmeditomedine
- Keywords
- dexmedetomedine, sedation, interventional radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmeditomedineDrug
Also called Dexmedetomidine at 0.6 mcg/kg/hr then 0.2 to 1 mcg/kg/hr.
| Study group | Role | What they receive |
|---|---|---|
| Dexmeditomedine | Experimental | Dexmedetomidine will be initiated at 0.6 mcg/kg/hr and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr. Receives: Drug: Dexmeditomedine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of sedation
It will be measured and recorded by using the Ramsay sedation score.
Measured: 1 hour
verbal analogue scale
assessment of pain using VAS score
Measured: 1 hour
Secondary outcomes (1)
patient satisfaction
assessment of patient satisfaction by 4 point scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Procedural SedationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M N Bashandy, National Cancer Institute, Egypt
- Investigators
- Wafaa T Salem, MD, Study chair, National Cancer Institute (NCI)Maie K Helaly, MD, Study director, National Cancer Institute (NCI)Ghada M Bashandy, MD, Principal investigator, National Cancer Institute (NCI)Ayat A Hassan, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180737
- Sponsor's protocol ID
- Dexmedetomidine sedation
- Acronym
- Dexmed
- Status last verified
- Apr 2016
- First submitted
- 30 Jun 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. doi: 10.1097/00000542-200411000-00005.
PubMed 15505441Scher CS, Gitlin MC. Dexmedetomidine and low-dose ketamine provide adequate sedation for awake fibreoptic intubation. Can J Anaesth. 2003 Jun-Jul;50(6):607-10. doi: 10.1007/BF03018650.
PubMed 12826556
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Role of Dexmedetomidine as a Sole Agent in Sedation of Cancer Patients Undergoing Radiological Interventional Procedures
- ClinicalTrials.gov ID
- NCT02180737
- Acronym / sponsor ID
- Dexmed / Dexmedetomidine sedation
- Conditions
- Procedural Sedation
- Keywords
- dexmedetomedine, sedation, interventional radiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmeditomedine | Experimental | Drug: DexmeditomedineDexmedetomidine will be initiated at 0.6 mcg/kg/hr and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18-65 years old
- ASA physical status of I-II
- Expected procedure lasting at least 30 minutes
Key exclusion criteria (4 listed)
- Unstable cardiac status (life-threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction and third-degree heart block.
- An alpha2-agonist or antagonist within 14 days before the scheduled procedure.
- patients received an IV opioid within 1 h, or an oral or IM opioid within 4 h of the start of study drug administration.
- Patients who are allergic to Dexmedetomidine or alpha 2-agonists.
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 |
|---|---|---|
| DexmeditomedineAlso: Dexmedetomidine at 0.6 mcg/kg/hr then 0.2 to 1 mcg/kg/hr. | Drug | Dexmeditomedine |
Primary outcome
Degree of sedation
Time frame: 1 hour
It will be measured and recorded by using the Ramsay sedation score.
verbal analogue scale
Time frame: 1 hour
assessment of pain using VAS score
1 secondary outcome
patient satisfaction
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Results publication: PubMed 15505441Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. doi: 10.1097/00000542-200411000-00005.
- Results publication: PubMed 12826556Scher CS, Gitlin MC. Dexmedetomidine and low-dose ketamine provide adequate sedation for awake fibreoptic intubation. Can J Anaesth. 2003 Jun-Jul;50(6):607-10. doi: 10.1007/BF03018650.
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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.
Wafaa T Salem, MD study chair
National Cancer Institute (NCI)
Maie K Helaly, MD study director
National Cancer Institute (NCI)
Ghada M Bashandy, MD principal investigator
National Cancer Institute (NCI)
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 Dexmeditomedine in people with Procedural Sedation, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 4 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 19 Apr 2016. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of sedation (time frame: 1 hour). The study lists 2 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 NCT02180737, which also lists 2 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 19 Apr 2016.