Sedation
Conditions
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.
Interventions
DRUGOTM Dexmedetomidine 1µg/ kg.
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
DRUGOTM Dexmedetomidine 0.75µg/ kg.
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
DRUGOTM 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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I - II. * Aged between 20 and 60 years. * Scheduled for modified radical mastectomy
Exclusion criteria
* Cardiac disease. * Hepatic disease. * Renal disease. * History of alcohol or drug abuse. * Patients with a known allergy to the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 360 minutes. | Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation preoperative | 30 minutes | Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration |
| Blood pressure preoperative | 30 minutes. | Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration. |
| Heart rate preoperative | 30 minutes | Heart rate will be recorded every 5 minutes 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 |
Countries
Egypt
Outcome results
None listed