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

• Conditions: 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.

• Registration Number: EUCTR2009-013543-11-GB
• Lead Sponsor: James Cook University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 182

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

Exclusion Criteria

Anaesthetist is unable to perform spinal anaesthesia. Pregnancy induced hypertension. Essential hypertension. Diabetes. Non-English speaker. Hypersensitivity to any of the study drugs. Anticoagulant therapy. Age < 18 years. BMI > 45.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.;Primary end point(s): The primary outcome will be the incidence of nausea during spinal anaesthesia for Caesarean section after delivery of the baby.