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Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.

NCT03120247 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-08-01

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2019-06-01
Completion
2019-07-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120247 on ClinicalTrials.gov