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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEX I | Active Comparator | 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. |
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| DEX II | Active Comparator | 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 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTM Dexmedetomidine 1µg/ kg. | Drug | Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax) | 360 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation preoperative | Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration | 30 minutes |
| Blood pressure preoperative | Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saher A Mohamed, MD | Assistant professor in anesthesia and pain management, South Egypt Cancer Institute, faculty of medicine, Assiut university. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Egypt cancer institute, Assiut university | Asyut | Assiut Governorate | 715715 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32889844 | Derived | Mohamed SA, Abdel-Ghaffar HS, Hassan NA, El Sherif FA, Shouman SA, Omran MM, Hassan SB, Allam AAAE, Sayed DG. Pharmacokinetics and Pharmacodynamics of 3 Doses of Oral-Mucosal Dexmedetomidine Gel for Sedative Premedication in Women Undergoing Modified Radical Mastectomy for Breast Cancer. Anesth Analg. 2021 Feb 1;132(2):456-464. doi: 10.1213/ANE.0000000000005108. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
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|
| OTM Dexmedetomidine 0.75µg/ kg. | Drug | Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. |
|
|
| OTM Dexmedetomidine 0.5µg/ kg. | Drug | Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. |
|
|
| 30 minutes. |
| Heart rate preoperative | Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration. | 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 | 360 minutes. |