Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation

Summary

The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.

Timeline

Start

2011-06-03

Primary completion

2011-11-18

Completion

2011-11-18

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Dexmedetomidine 0.5 mcg/kg; p = 0.003; Mantel Haenszel NCT01438957 ↗

registry analysis (superiority test); Placebo vs Dexmedetomidine 1.0 mcg/kg; p <0.001; Mantel Haenszel NCT01438957 ↗

Publications

• Inagaki Y, Yamakage M, Sakamoto A, Okayama A, Oya N, Hiraoka T, Morita K. The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study. Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. eCollection 2022 Feb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	0.067 ug/kg	Intravenous
Subject	Dexmedetomidine	Other / unclassified	0.25 ug/kg	Intravenous
Subject	Dexmedetomidine	Other / unclassified	0.5 ug/kg	Intravenous
Subject	Dexmedetomidine	Other / unclassified	1 ug/kg	Intravenous

Indications

No indication recorded.