Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.

NCT03120247 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: IORG0006563/no. 377
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax)

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

  360 minutes.

Secondary Outcomes (4)

• Sedation preoperative

  30 minutes

• Blood pressure preoperative

  30 minutes.

• Heart rate preoperative

  30 minutes

• Area under the plasma concentration versus time curve (AUC)

  360 minutes.

Study Arms (3)

DEX I

ACTIVE COMPARATOR

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.

DEX II

ACTIVE COMPARATOR

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.

DEX III

ACTIVE COMPARATOR

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.

Interventions

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.

Also known as: Precedex

DEX I

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.

Also known as: Precedx

DEX II

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.

Also known as: Precedex

DEX III

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I - II.
• Aged between 20 and 60 years.
• Scheduled for modified radical mastectomy

You may not qualify if:

• Cardiac disease.
• Hepatic disease.
• Renal disease.
• History of alcohol or drug abuse.
• Patients with a known allergy to the study drug

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

South Egypt cancer institute, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32889844 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Saher A Mohamed, MD

  Assistant professor in anesthesia and pain management, South Egypt Cancer Institute, faculty of medicine, Assiut university.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Model Details: Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 19, 2017
• Study Start: April 5, 2017
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)