A Phase 2/3 interventional study of OTM Dexmedetomidine 1µg/ kg. and OTM Dexmedetomidine 0.75µg/ kg. in Sedation, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by Assiut University · Phase 2/3, Interventional, and Treatment
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 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.
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OTM Dexmetetomidine 1µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Drug: OTM Dexmedetomidine 1µg/ kg.
OTM Dexmetetomidine0.75µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Drug: OTM Dexmedetomidine 0.75µg/ kg.
OTM Dexmetetomidine 0.5µg/kg. Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Drug: OTM Dexmedetomidine 0.5µg/ kg.
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Also known as: Precedex
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Also known as: Precedx
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Also known as: Precedex
Peak Plasma Concentration (Cmax)
Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)
Time frame: 360 minutes.
Sedation preoperative
Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration
Time frame: 30 minutes
Blood pressure preoperative
Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Time frame: 30 minutes.
Heart rate preoperative
Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Time frame: 30 minutes
Area under the plasma concentration versus time curve (AUC)
Two milliliters of blood will be collected for determination of Area under the plasma concentration versus time
Time frame: 360 minutes.
Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Assiut University