Dexmedetomidine for Sedation During Radiological Interventional Procedures
Dexmed
Evaluation of Role of Dexmedetomidine as a Sole Agent in Sedation of Cancer Patients Undergoing Radiological Interventional Procedures
1 other identifier
interventional
40
1 country
1
Brief Summary
Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 19, 2016
April 1, 2016
11 months
June 30, 2014
April 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Degree of sedation
It will be measured and recorded by using the Ramsay sedation score.
1 hour
verbal analogue scale
assessment of pain using VAS score
1 hour
Secondary Outcomes (1)
patient satisfaction
24 hours
Study Arms (1)
Dexmeditomedine
EXPERIMENTALDexmedetomidine 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age from 18-65 years old
- ASA physical status of I-II
- Expected procedure lasting at least 30 minutes
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute-Egypt
Cairo, 112796, Egypt
Related Publications (2)
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.
PMID: 15505441RESULTScher 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.
PMID: 12826556RESULT
Study Officials
- STUDY CHAIR
Wafaa T Salem, MD
National Cancer Institute (NCI)
- STUDY DIRECTOR
Maie K Helaly, MD
National Cancer Institute (NCI)
- PRINCIPAL INVESTIGATOR
Ghada M Bashandy, MD
National Cancer Institute (NCI)
- PRINCIPAL INVESTIGATOR
Ayat A Hassan, MD
National Cancer Institute (NCI)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 3, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
April 19, 2016
Record last verified: 2016-04