Gender Influence on Torsadogenic Actions of Droperidol.
Ključne besede
Povzetek
Datumi
Nazadnje preverjeno: | 04/30/2019 |
Prvič predloženo: | 01/29/2019 |
Predviden vpis oddan: | 05/07/2019 |
Prvič objavljeno: | 05/08/2019 |
Zadnja posodobitev oddana: | 05/09/2019 |
Zadnja posodobitev objavljena: | 05/13/2019 |
Dejanski datum začetka študija: | 04/22/2019 |
Predvideni datum primarnega zaključka: | 11/30/2020 |
Predvideni datum zaključka študije: | 11/30/2020 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Droperidol group
Faza
Skupine rok
Roka | Intervencija / zdravljenje |
---|---|
Other: Droperidol group Droperidol (Xomolix, Kyowa Kirin) 1.25 mg i.v. bolus | Drug: Droperidol group An electrocardiogram analysis in: 5,10,15,20 minutes after injection of 1.25 mg of droperidol used as PONV prophylaxis. |
Merila upravičenosti
Starost, primerna za študij | 18 Years Za 18 Years |
Spol, upravičen do študija | All |
Sprejema zdrave prostovoljce | Da |
Merila | Inclusion Criteria: - age between 18 and 45 years old - ASA (American Society of Anaesthesiologists) physical status 1 and 2 Exclusion Criteria: - lack of informed consent - ASA (American Society of Anaesthesiologists) physical status 3 and more - admittance of repolarisation affecting drugs like: antiarrhythmics (Williams group I-IV), psychotropics, macrolides, antireflux drugs - ischaemic heart disease - cardiac failure NYHA (Hew York Heart Association) 1 and more - congenital or acquired heart defects - arrhythmias in anamnesis - hormonal contraception, - postmenopausal - neoplasms |
Izid
Primarni izidni ukrepi
1. QT and corrected QT interval time [Change from baseline QT and corrected QT interval time at 5,10,15 and 20 minutes after administration of 1.25 mg droperidol]
2. Time interval between T wave peak and T wave end [Change from baseline T peak - T end time at 5,10,15 and 20 minutes after administration of 1.25 mg droperidol.]