Clinical trial NCT03120247: Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.
Official title: Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sedation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 36
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 360 minutes.
Secondary outcomes:
measure: Sedation preoperative
timeFrame: 30 minutes
measure: Blood pressure preoperative
timeFrame: 30 minutes.
measure: Heart rate preoperative
timeFrame: 30 minutes
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 360 minutes.
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: South Egypt cancer institute, Assiut university
state: Assiut Governorate
Study officials:
affiliation: Assistant professor in anesthesia and pain management, South Egypt Cancer Institute, faculty of medicine, Assiut university.
name: Saher A Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.