A comparison of nausea with two routine ways of managing low blood pressure after delivery of the baby during spinal anaesthesia for Caesarean section.

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2010
INTERVENTION: Trade Name: Phenylephrine Injection BP Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Phenylephrine Injection BP Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 100‐ CONDITION: We are investigating nausea associated with hypotension caused by spinal anaesthesia in healthy women undergoing elective Caesarean section. NICE recommend phenylephrine in this population. The aim is to find out whether prophylactic phenylephrine reduces nausea. PRIMARY OUTCOME: Main Objective: We are trying to find out if a prophylactic infusion of phenylephrine reduces maternal nausea after delivery of the baby during spinal anaesthesia for Caesarean section. Primary end point(s): The primary outcome will be the incidence of nausea during spinal anaesthesia for Caesarean section after delivery of the baby. Secondary Objective: We will also monitor the severity any nausea, and the incidence and severity of faintness. Faintness is a very common symptom of low blood pressure and can occur with or without nausea. Although this study is primarily interested in nausea, we would like to gather information about the frequency and severity of faintness. INCLUSION CRITERIA: Normal healthy women, or those with mild systemic disease that is well controlled and does not limit activity, scheduled for elective Caesarean section under spinal anaesthesia. Singleton fetus, at least 36 weeks gestation, with no known abnormality. Under the care of a specialist Obstetrician at the James Cook University Hospital who consents to his/her patients being included in the trial. Patients giving informed consent to participate in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 75791ddae3e193cff17a4933c0d276254408e450
First added on: Aug 22, 2024