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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02180737
Other study ID # Dexmedetomidine sedation
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2014
Last updated April 17, 2016
Start date January 2014
Est. completion date January 2015

Study information

Verified date April 2016
Source National Cancer Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age from 18-65 years old

- ASA physical status of I-II

- Expected procedure lasting at least 30 minutes

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexmeditomedine


Locations

Country Name City State
Egypt National Cancer Institute-Egypt Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & 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 volun — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of sedation It will be measured and recorded by using the Ramsay sedation score. 1 hour Yes
Primary verbal analogue scale assessment of pain using VAS score 1 hour No
Secondary patient satisfaction assessment of patient satisfaction by 4 point scale 24 hours No
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