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.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-013543-11-GB
• Date of registration: 14/10/2010
• Prospective Registration: No
• Primary sponsor: James Cook University Hospital
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 19/10/2009
• Target sample size: 182
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013543-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male:

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

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-

Primary Outcome(s)

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.

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 ID(s)

2009057

N/A