Hypotension during spinal anaesthesia for Caesarean section Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy women scheduled for elective Caesarean section under spinal anaesthesia 2. Singleton fetus, at least 36 weeks gestation, with no known abnormality 3. Under the care of a specialist Obstetrician at the James Cook University Hospital who consents to his/her patients being included in the trial 4. Patients giving informed consent to participate in the trial
Exclusion criteria
Exclusion criteria: 1. Pregnancy induced hypertension 2. Essential hypertension 3. Baseline systolic arterial pressure >145 mmHg, even if there is no history of hypertension 4. Diabetes 5. Age below 18 years 6. BMI over 45 at term 7. Anaesthetist is unable to perform spinal anaesthesia, spinal anaesthesia alone is not considered adequate for surgery to start, or general anaesthesia is required before delivery of the baby 8. Withdrawal of patient?s or obstetrician?s consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Association between the heart rate at 3-minutes post-spinal and the lowest arterial pressure recorded during spinal anaesthesia before delivery of the baby 2. A comparison of the heart rate at 3-minutes post spinal for those patients that develop hypotension before delivery of the baby compared with those that do not Primary and secondary outcome data will be recorded by a dedicated researcher (an anaesthetist or research nurse) who will be present in addition the patient?s usual anaesthetist. The heart rate and arterial pressure will be recorded at baseline by the researcher when the patients are admitted to the hospital on the day of their surgery, using a non-invasive blood pressure device. Heart rate and arterial pressure will also be recorded when the patient is first brought in to the anaesthetic room and during induction of spinal anaesthesia. Following the spinal anaesthetic injection, and during the operation, heart rate will be measured continuously by an electrocardiogram and maternal arterial pressure will be measured every two minutes with a non-invasive blood pressure device. Before the induction of spinal anesthesia the patients will be asked to immediately report any feeling of nausea or faintness that they may have during the spinal anaesthetic. The researcher will also ask the patient every five minutes whether they have any nausea or faintness. If the patient feels nauseated an additional arterial pressure reading will be measured to assess whether this is associated with low arterial pressure and to guide treatment. Data will only be recorded up until delivery of the baby by the researcher, at which point the study ends. There will be no further data collection or patient follow up following delivery of the baby. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. A comparison of the heart rate at 3-minutes post spinal for those patients that develop nausea before delivery of the baby compared with those that do not 2. Association between the heart rate at 3-minutes post-spinal and the the dose of phenylephrine given during spinal anaesthesia before delivery of the baby | — |
Countries
United Kingdom