Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.

Sedation Clinical Trial

— OTM/DEX/PK  

Official title:

Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120247
• Other study ID #: IORG0006563/no. 377
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 5, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• OTM 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.
• OTM 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.
• OTM 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.

Locations

Country	Name	City	State
Egypt	South Egypt cancer institute, Assiut university	Asyut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)	360 minutes.
Secondary	Sedation preoperative	Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration	30 minutes
Secondary	Blood pressure preoperative	Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration.	30 minutes.
Secondary	Heart rate preoperative	Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration.	30 minutes
Secondary	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.