South Egypt cancer institute, Assiut university
Asyut, Assiut Governorate, 715715, Egypt
NCT Number: NCT03120247
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.
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Notify Me20 year–60 year
Female
Interventional
Phase 2 / Phase 3
Asyut, Assiut Governorate, 715715, Egypt
The alpha2-adrenoceptor agonist, dexmedetomidine, was originally developed as a sedative and analgesic drug for use in intensive care. However, it has a number of unique pharmacodynamic properties, which also make it useful in anesthesia including; decreased MAC, analgesia without respiratory depression and a significant reduction in catecholamine secretion. Also it has been used off-label as an adjunctive agent for sedation and analgesia in patients in the critical care unit and for sedation during non-invasive procedures in radiology. It also has a potential role as part of anesthesia care to prevent emergence delirium and post-anesthesia shivering.
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.
The current literature is focused in studying the sedative and analgesic effects of intravenously administered dexmedetomidine. Pharmacodynamics and pharmacokinetic studies undertaken on alternative routes of dexmedetomidine administration are lacking. The pharmacokinetic properties of trans-mucosal administration of dexmedetomidine have been demonstrated in one study only, and the clinical effects of non-parenteral administration of dexmedetomidine have been described in anecdotal case reports.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Other names: Precedex
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Other names: Precedx
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Other names: Precedex
Time frame: 360 minutes.
Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)
Time frame: 30 minutes
Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration
Time frame: 30 minutes.
Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Time frame: 30 minutes
Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Time frame: 360 minutes.
Two milliliters of blood will be collected for determination of Area under the plasma concentration versus time
Assiut University
Other
Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy
Acronym: OTM/DEX/PK
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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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