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CompletedNCT02180737DexmedUpdated Apr 19, 2016

Dexmedetomidine for Sedation During Radiological Interventional Procedures

A Phase 4 interventional study of Dexmeditomedine in Procedural Sedation, sponsored by National Cancer Institute, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by National Cancer Institute, Egypt · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.

02

Conditions studied

  • Procedural Sedation

Keywords

  • dexmedetomedine
  • sedation
  • interventional radiology
03

In context

Lead sponsor

National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age from 18-65 years old
  • ASA physical status of I-II
  • Expected procedure lasting at least 30 minutes

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Dexmeditomedine

    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.

    Drug: Dexmeditomedine

Interventions

  • DrugDexmeditomedine

    Also known as: Dexmedetomidine at 0.6 mcg/kg/hr then 0.2 to 1 mcg/kg/hr.

06

What researchers measure

Primary outcomes

  1. Degree of sedation

    It will be measured and recorded by using the Ramsay sedation score.

    Time frame: 1 hour

  2. verbal analogue scale

    assessment of pain using VAS score

    Time frame: 1 hour

Secondary outcomes

  1. patient satisfaction

    assessment of patient satisfaction by 4 point scale

    Time frame: 24 hours

07

Study locations

1 site
  • National Cancer Institute-Egypt
    Cairo, 112796, Egypt
08

References and documents

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 15505441 ↗
  • Scher 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02180737
Lead sponsor
National Cancer Institute, Egypt
Responsible party
Ghada M N Bashandy (Dr, National Cancer Institute, Egypt) — Principal investigator
First posted
Jul 3, 2014
Start date
Jan 2014
Primary completion
Dec 2014
Completion
Jan 2015
Last update
Apr 19, 2016

Study contacts

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)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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