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

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ClinicalTrials.gov Identifier: NCT03120247
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE April 5, 2017
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2017)
Peak Plasma Concentration (Cmax) [ Time Frame: 360 minutes. ]
Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2017)
  • Sedation preoperative [ Time Frame: 30 minutes ]
    Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration
  • Blood pressure preoperative [ Time Frame: 30 minutes. ]
    Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
  • Heart rate preoperative [ Time Frame: 30 minutes ]
    Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 360 minutes. ]
    Two milliliters of blood will be collected for determination of Area under the plasma concentration versus time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.
Official Title  ICMJE Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sedation
Intervention  ICMJE
  • 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 Name: Precedex
  • 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 Name: Precedx
  • 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 Name: Precedex
Study Arms  ICMJE
  • 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.
    Intervention: Drug: OTM Dexmedetomidine 1µg/ kg.
  • 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.
    Intervention: Drug: OTM Dexmedetomidine 0.75µg/ kg.
  • 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.
    Intervention: Drug: OTM Dexmedetomidine 0.5µg/ kg.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2017)
24
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03120247
Other Study ID Numbers  ICMJE IORG0006563/no. 377
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hala Saad Abdel-Ghaffar, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saher A Mohamed, MD Assistant professor in anesthesia and pain management, South Egypt Cancer Institute, faculty of medicine, Assiut university.
PRS Account Assiut University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP