PMID- 35221757
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220502
IS  - 0513-5710 (Print)
IS  - 1346-8049 (Electronic)
IS  - 0513-5710 (Linking)
VI  - 65
IP  - 1
DP  - 2022 Feb
TI  - The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under 
      Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled 
      Study.
PG  - 14-25
LID - 10.33160/yam.2022.02.002 [doi]
AB  - BACKGROUND: Only a few studies have been reported on the use of dexmedetomidine 
      for sedating surgical patients requiring epidural or spinal anesthesia. We 
      conducted a randomized, double-blind, placebo-controlled, parallel-group study at 
      12 hospitals in Japan. METHODS: Adult patients were randomly allocated to receive 
      an intravenous administration of placebo or dexmedetomidine at 0.067, 0.25, 0.5 
      or 1.0 microg/kg over 10 min after epidural or spinal anesthesia. All dexmedetomidine 
      groups received dexmedetomidine 0.2-0.7 microg/kg/h to maintain an Observer's 
      Assessment of Alertness/Sedation Scale (OAA/S) score of </= 4; however, propofol 
      was administered to rescue patients who exceeded this score. Surgery was then 
      started 15 min after study drug infusion in patients with OAA/S score of </= 4. The 
      primary endpoint was the percentage of patients not requiring rescue propofol to 
      achieve and maintain an OAA/S score of </= 4. RESULTS: Of the 120 enrolled and 
      randomized patients, 119 were treated the study: 22 received placebo and 97 
      received dexmedetomidine (23-25 patients per dose). Significantly more patients 
      did not require propofol in the dexmedetomidine 0.5 and 1.0 microg/kg groups (68.0% 
      and 80.0%, respectively) compared to the placebo group (22.7%) (P = 0.003 and P < 
      0.001, respectively). Common adverse events (AEs) were protocol-defined 
      respiratory depression, bradycardia and hypotension. There was no significant 
      difference in the incidence of AEs between the dexmedetomidine and the placebo 
      groups. CONCLUSION: We concluded that loading doses of 0.5 and 1.0 microg/kg 
      dexmedetomidine, followed by an infusion at a rate of 0.2-0.7 microg/kg/h, provide 
      effective and well-tolerated sedation for surgical patients during epidural or 
      spinal anesthesia. Clinical trials.gov identifier: NCT01438957.
CI  - (c)2022 Tottori University Medical Press.
FAU - Inagaki, Yoshimi
AU  - Inagaki Y
AD  - Department of Anesthesiology and Critical Care Medicine, School of Medicine, 
      Faculty of Medicine, Tottori University, Yonago 683-8504, Japan.
FAU - Yamakage, Michiaki
AU  - Yamakage M
AD  - Department of Anesthesiology, Sapporo Medical University School of Medicine, 
      Sapporo 060-8556, Japan.
FAU - Sakamoto, Atsuhiro
AU  - Sakamoto A
AD  - Department of Anesthesiology, Nippon Medical School, Tokyo 113-8602, Japan.
FAU - Okayama, Akifumi
AU  - Okayama A
AD  - Clinical Statistics Group 2, Biometrics & Data Management, Pfizer R&D Japan, 
      Tokyo 151-8589, Japan.
FAU - Oya, Nobuyo
AU  - Oya N
AD  - Clinical Development Department, Maruishi Pharmaceutical Co., Ltd., Osaka 
      538-0042, Japan.
FAU - Hiraoka, Takehiko
AU  - Hiraoka T
AD  - Clinical Development Department, Maruishi Pharmaceutical Co., Ltd., Osaka 
      538-0042, Japan.
FAU - Morita, Kiyoshi
AU  - Morita K
AD  - Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical 
      Science, Okayama700-8558, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01438957
PT  - Journal Article
DEP - 20220104
PL  - Japan
TA  - Yonago Acta Med
JT  - Yonago acta medica
JID - 0414002
PMC - PMC8857668
OTO - NOTNLM
OT  - anesthesia
OT  - dexmedetomidine
OT  - epidural
OT  - propofol
OT  - spinal
COIS- CONFLICTS OF INTEREST: This study was funded by Hospira Japan Co., Ltd., Inc. 
      which was acquired by Pfizer Inc. in September 2015. Pfizer Japan Inc. and 
      Pharmaceutical Co., Ltd. co-developed dexmedetomidine. The data management and 
      statistical analysis services were conducted by CIMIC Co., Ltd. and were funded 
      by Pfizer. YI, MY, AS, NO, TH, and KM declare no conflicts of interest. AO is an 
      employee of Pfizer.
EDAT- 2022/03/01 06:00
MHDA- 2022/03/01 06:01
PMCR- 2022/01/04
CRDT- 2022/02/28 05:32
PHST- 2021/09/16 00:00 [received]
PHST- 2021/12/09 00:00 [accepted]
PHST- 2022/02/28 05:32 [entrez]
PHST- 2022/03/01 06:00 [pubmed]
PHST- 2022/03/01 06:01 [medline]
PHST- 2022/01/04 00:00 [pmc-release]
AID - 2022.02.002 [pii]
AID - 10.33160/yam.2022.02.002 [doi]
PST - epublish
SO  - Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. 
      eCollection 2022 Feb.