drugset / Trial / NCT00318955

Post-Marketing Clinical Study to Assess Efficacy and Safety of Dexmedetomidine in Post-Operative Patients

Phase 4 Completed 85 enrolled Pfizer Maruishi Pharmaceutical · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess efficacy and safety of dexmedetomidine at the time of extubation and after extubation, in patients requiring postoperative sedation in the ICU.

Timeline

Start: 2005-11
Primary completion: 2006-08
Completion: 2006-08

Publications

Background Aitkenhead AR. Analgesia and sedation in intensive care. Br J Anaesth. 1989 Aug;63(2):196-206. doi: 10.1093/bja/63.2.196. No abstract available.
Background Minoru Kaneshiro. Analgesic and Sedatin during mechanical ventilation, ICU and CCU 14:14643-648,1990
Background Syu Matsukawa, et.al.Sedation during ventilation control, ICU and CCU 14:603-608,1990
Background Megumu Tagami et.al. Post-operative analgesic and sedation control,
Background Greenblatt DJ, Divoll M, Abernethy DR, Ochs HR, Shader RI. Clinical pharmacokinetics of the newer benzodiazepines. Clin Pharmacokinet. 1983 May-Jun;8(3):233-52. doi: 10.2165/00003088-198308030-00003.
Background Hidekazu Yukioka, et.al. Current status of analgesic and sedation control in ICU. Japan ICU Treatment Association's Magazine 1:13-19, 1994
Background Masayoshi Hyodo et.al. Anesthetic Science, 10th edition, Kinpodo, ppl 213-219
Background Ikuto Yoshiya. Section 4; Pharmacology for Anesthesia, Introduction to Anesthesiology, 7th edition, Nagai Shoten,pp439-447, 1993
Background Ikuto Yoshiya: Sedation and Analgesia for Intensive Care Patients. Anesthesia 21(2):2-6, 333-337, 2000
Background Costas Katsanoulas. Concluding Remarks: Redefining Intensive Care Unit Sedation, International Congress and Symposium Series 221, 83-88
Background Mantz,J., Singer,M. Importance of Patient Orientation and Rousability as Components of Intensive Care Unit Sedation, International Congress and Symposium Series 221, 23-29
Background Hewitt PB. Subjective follow-up of patients from a surgical intensive therapy ward. Br Med J. 1970 Dec 12;4(5736):669-73. doi: 10.1136/bmj.4.5736.669.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	—	—
Comparator	Propofol	Small molecule	—	—

Indications

No indication recorded.