A comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
516
5mg/2ml
2ml
The primary endpoint was the composite measure complete response
defined as no episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after wound closure
Time frame: 24 hours after the end of surgery
Incidence of no Nausea
Count of patients experiencing an episode of no nausea scored \< 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery
Time frame: 24 hours after end of surgery
Incidence of moderate and severe Nausea
Count of participants with nausea score \> 4 on 0-10 verbal response scale
Time frame: 24 hours after end of surgery
Incidence of Emesis (Vomiting/Retching)
An assessment of a participant experiencing an episode of emesis (vomiting/ retching) during the 24hours after the completion of the surgery
Time frame: 24 hours after end of surgery
Use of Rescue Medication
Time frame: 24 hours after end of surgery
Time to First Violation of Criteria for PONV
Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery
Time frame: 24 hours after end of surgery
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