Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.
- Conditions
- Sedation
- Interventions
- Registration Number
- NCT03120247
- Lead Sponsor
- Assiut University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
- ASA physical status I - II.
- Aged between 20 and 60 years.
- Scheduled for modified radical mastectomy
- Cardiac disease.
- Hepatic disease.
- Renal disease.
- History of alcohol or drug abuse.
- Patients with a known allergy to the study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DEX II OTM Dexmedetomidine 0.75µg/ 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. DEX III OTM Dexmedetomidine 0.5µg/ 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. DEX I OTM Dexmedetomidine 1µg/ kg. 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.
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) 360 minutes. Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)
- Secondary Outcome Measures
Name Time Method Heart rate preoperative 30 minutes Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Sedation preoperative 30 minutes Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration
Area under the plasma concentration versus time curve (AUC) 360 minutes. Two milliliters of blood will be collected for determination of Area under the plasma concentration versus time
Blood pressure preoperative 30 minutes. Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Trial Locations
- Locations (1)
South Egypt cancer institute, Assiut university
🇪🇬Asyut, Assiut Governorate, Egypt