Dexmedetomidine for Sedation During Radiological Interventional Procedures

NCT ID: NCT02180737

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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Conditions

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Procedural Sedation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmeditomedine

Intervention Type DRUG

Interventions

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Dexmeditomedine

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Ghada M N Bashandy

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wafaa T Salem, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Maie K Helaly, MD

Role: STUDY_DIRECTOR

National Cancer Institute (NCI)

Ghada M Bashandy, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Ayat A Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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National Cancer Institute-Egypt

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 15505441 (View on PubMed)

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.

Reference Type RESULT
PMID: 12826556 (View on PubMed)

Other Identifiers

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Dexmedetomidine sedation

Identifier Type: -

Identifier Source: org_study_id

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