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Completed

NCT Number: NCT02180737

Dexmedetomidine for Sedation During 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.

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Key information

Conditions

Procedural Sedation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cancer Institute-Egypt

Cairo, 112796, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmeditomedine

Drug

Other names: Dexmedetomidine at 0.6 mcg/kg/hr then 0.2 to 1 mcg/kg/hr.

Primary outcomes

  1. Degree of sedation

    Time frame: 1 hour

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

  2. verbal analogue scale

    Time frame: 1 hour

    assessment of pain using VAS score

Secondary outcomes

  1. patient satisfaction

    Time frame: 24 hours

    assessment of patient satisfaction by 4 point scale

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Acronym: Dexmed

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 3, 2014
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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