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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03120247
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
26.8
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: OTM Dexmedetomidine 1µg/ kg.
  • Drug: OTM Dexmedetomidine 0.75µg/ kg.
  • Drug: OTM Dexmedetomidine 0.5µg/ kg.
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidinePharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy
Actual Study Start Date :
Apr 5, 2017
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: DEX I

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.

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.
Other Names:
  • Precedex

    		•
    Active Comparator: DEX II

    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.

    Drug: 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.
    Other Names:
  • Precedx

    		•
    Active Comparator: DEX III

    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.

    Drug: 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.
    Other Names:
  • Precedex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak Plasma Concentration (Cmax) [360 minutes.]

      Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)

    Secondary Outcome Measures

    1. Sedation preoperative [30 minutes]

      Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration

    2. Blood pressure preoperative [30 minutes.]

      Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration.

    3. Heart rate preoperative [30 minutes]

      Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration.

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Egypt cancer institute, Assiut university Asyut Assiut Governorate Egypt 715715

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Saher A Mohamed, MD, Assistant professor in anesthesia and pain management, South Egypt Cancer Institute, faculty of medicine, Assiut university.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Saad Abdel-Ghaffar, Assistant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut University
    ClinicalTrials.gov Identifier:
    NCT03120247
    Other Study ID Numbers:
    • IORG0006563/no. 377
    First Posted:
    Apr 19, 2017
    Last Update Posted:
    Aug 1, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of Aug 1, 2019