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Completed

NCT Number: NCT03120247

Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

South Egypt cancer institute, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTM Dexmedetomidine 1µg/ kg.

Drug

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

OTM Dexmedetomidine 0.75µg/ kg.

Drug

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

OTM Dexmedetomidine 0.5µg/ kg.

Drug

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

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 360 minutes.

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

Secondary outcomes

  1. Sedation preoperative

    Time frame: 30 minutes

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

  2. Blood pressure preoperative

    Time frame: 30 minutes.

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

  3. Heart rate preoperative

    Time frame: 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)

    Time frame: 360 minutes.

    Two milliliters of blood will be collected for determination of Area under the plasma concentration versus time

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: OTM/DEX/PK

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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