Hypotension
Conditions
Keywords
obstetric, anesthesia, hypotension, arterial pressure, measurement techniques
Brief summary
The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive arterial pressure (NIAP)measurement during spinal anaesthesia for cesarean section .
Detailed description
Peri-operative hypotension and fluctuation of arterial blood pressure (BP) during spinal anaesthesia are common. Hypotension causes maternal side-effects such as unconsciousness, dizziness, nausea, and vomiting. The potential fetal side-effects are caused by a reduction in the uterine blood flow with consequent reduced oxygen supply and acidosis reflected by impaired blood gas analyses and impaired Apgar scores. Because of the potential harm to the fetus and the dependency of fetal oxygenation on maternal arterial pressure (AP), it has been strongly recommended to closely monitor mother's arterial pressure and to treat hypotension immediately. Non-invasive arterial pressure (NIAP) measurement is a common method for monitoring in clinical. These hypotension episodes probably would be detected with delay by NIAP measurement on account of its discontinuous. A monitor for continuous non-invasive arterial pressure monitoring (CNAPTM Monitor 500, CNSystems Medizintechnik AG,Graz, Austria) using the volume-clamped method. It can monitor timely and provide beat-to-beat value of arterial pressure. The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal.
Interventions
DRUGphenylephrine
When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug in Group C and Group N.If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled for elective caesarean section with spinal anaesthesia * pregnancy week above 36
Exclusion criteria
* age\<18 yr * cardiac arrhythmia * vascular pathologies of the upper limbs (recent vascular surgery, Raynaud's disease， vascular stenosis) * contraindication for spinal anaesthesia * emergency case
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement | between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins | (baseline SBP-minimum SBP)/baseline SBP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal outcome was assessed with Apgar scores | between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins | — |
| umbilical cord blood gases analysis at birth | between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins | — |
| Detecting the occurrence of hypotension | between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins | systolic blood pressure decreased by over 20% of the baseline or systolic blood pressure lower than 100mmHg |
| the incidence of dizziness on account of hypotension | between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins | assessment:yes=patient had dizziness,no=patient had no dizziness |
| the incidence of dyspnea on account of hypotension | between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins | assessment:yes=patient had dyspnea,no=patient had no dyspnea |
| the incidence of nausea and vomiting on account of hypotension | between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins | The presence of nausea and vomiting was measured on a 3-point scale of 1,2, and 3 indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively. Assessments were done at 1-minute intervals after the spinal injection until 25 min. |
Countries
China
Contacts
Primary ContactHan
Outcome results
None listed