Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine. (OTM/DEX/PK)

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sedation

Treatments: Drug: OTM Dexmedetomidine 1µg/ kg.; Drug: OTM Dexmedetomidine 0.5µg/ kg.; Drug: OTM Dexmedetomidine 0.75µg/ kg.

Study type: Interventional

Funder types: Other

Identifiers

NCT03120247

IORG0006563/no. 377

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

DEX I

Active Comparator group

Description:

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.

Treatment:

Drug: OTM Dexmedetomidine 1µg/ kg.

DEX II

Active Comparator group

Description:

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.

Treatment:

Drug: OTM Dexmedetomidine 0.75µg/ kg.

DEX III

Active Comparator group

Description:

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.

Treatment:

Drug: OTM Dexmedetomidine 0.5µg/ kg.