Dexmedetomidine for Sedation During Radiological Interventional Procedures

Procedural Sedation Clinical Trial

— Dexmed  

Official title:

Evaluation of Role of Dexmedetomidine as a Sole Agent in Sedation of Cancer Patients Undergoing Radiological Interventional Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180737
• Other study ID #: Dexmedetomidine sedation
• 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

• Procedural Sedation

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