Adverse Effect
Conditions
Keywords
Norepinephrine, Hypotension, Inferior Vena Cava Collapsibility Index, Cesarean Delivery
Brief summary
The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).
Detailed description
Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).
Interventions
DRUGnormal saline
a bolus of normal saline was given followed by normal saline infusion
DRUGNorepinephrine
a bolus of norepinephrine was given followed by norepinephrine infusion
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 18-45 years * American Society of Anesthesiologists physical status classification I to II * Scheduled for elective cesarean delivery under spinal anesthesia * Full-term, singleton, pregnant women
Exclusion criteria
* Height of no more than 150 centimeters * Body weight greater than 100 kg or BMI greater than 30 * Labor analgesia had been performed * Contraindication of spinal or epidural anesthesia * Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg * Hemoglobin \<7g/dl * Fetal distress or known abnormal fetal development * Severe vascular disease * Diabetes mellitus or cardiovascular disease or nervous system disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypotension | 1 to 20 minutes after subarachnoid block | SBP decreased to \<80% of the baseline value |
| Inferior vena cava collapsibility index | 5 to 20 minutes after subarachnoid block | CI = (dIVCmax - dIVCmin)/dIVCmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypertension | 1 to 20 minutes after subarachnoid block | Systolic blood pressure at or above 120% of baseline |
| Arterial base excess of fetal vein blood | Immediately after delivery | From umbilical vein blood gases |
| Pressure of oxygen of fetal vein blood | Immediately after delivery | From umbilical vein blood gases |
| The incidence of nausea and vomiting | 1 to 20 minutes after subarachnoid block | Presence of nausea and vomiting in patients after subarachnoid block |
| Number of rescue norepinephrine | Immediately to 20 minutes after subarachnoid block | a bolus of norepinephrine was given when SBP decreased to \<80% of the baseline value |
| APGAR score | 1min after delivery | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration |
| pH value of fetal vein blood | Immediately after delivery | From umbilical vein blood gases |
| The incidence of bradycardia | 1 to 20 minutes after subarachnoid block | Heart rate less than 55 bpm |
Countries
China
Outcome results
None listed