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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013543-11-GB

Enrollment

182

Registered

2010-10-14

Start date

2009-10-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

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: e

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 45.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026