Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.

NCT03120247 ↗

Phase 2/3 Completed 36 enrolled Assiut University

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2017-04-05
Primary completion: 2019-06-01
Completion: 2019-07-01

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dexmedetomidine	Other / unclassified	0.5 ug/kg	Oral
Comparator	Dexmedetomidine	Other / unclassified	0.75 ug/kg	Oral
Comparator	Dexmedetomidine	Other / unclassified	1 ug/kg	Oral

Indications

No indication recorded.