Adverse Effect
Conditions
Keywords
Preload, Inferior vena cava collapsibility index, Norepinephrine, Cesarean section, Dose-finding
Brief summary
The purpose of this study is to investigate the optimal preload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.
Detailed description
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, the investigator's study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of preload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal preload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section.
Interventions
DRUGControl group
No preload was given before spinal anesthesia.
DRUG4 ml/kg group.
4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
DRUG8 ml/kg group.
8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
DRUG12 ml/kg group.
12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 18-40 years * Primipara or multipara * Singleton pregnancy ≥37 weeks * American Society of Anesthesiologists physical status classification I to II * Scheduled for elective cesarean section under spinal anesthesia
Exclusion criteria
* Body height \< 150 cm * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2 * Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg * Hemoglobin \< 7g/dl * Fetal distress, or known fetal developmental anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC) | Baseline (before preload) | IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of severe post-spinal anesthesia hypotension. | 1-15 minutes after spinal anesthesia. | Systolic blood pressure (SBP) \< 60% of the baseline |
| The incidence of nausea and vomiting. | 1-15 minutes after spinal anesthesia. | Presence of nausea and vomiting in patients after spinal anesthesia |
| The incidence of bradycardia | 1-15 minutes after spinal anesthesia | Heart rate \< 55 beats/min. |
| The incidence of hypertension | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \>120% of the baseline |
| pH | Immediately after delivery | From umbilical arterial blood gases |
| The incidence of post-spinal anesthesia hypotension. | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \< 80% of the baseline. |
| Base excess | Immediately after delivery | From umbilical arterial blood gases |
| APGAR score | 1min after delivery | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration |
| Overall stability of systolic blood pressure control versus baseline | 1-15 minutes after spinal anesthesia. | Evaluated by performance error (PE). |
| Overall stability of heart rate control versus baseline | 1-15 minutes after spinal anesthesia. | Evaluated by performance error (PE). |
| Partial pressure of oxygen | Immediately after delivery | From umbilical arterial blood gases |
Countries
China
Outcome results
None listed