Adverse Effect
Conditions
Keywords
Norepinephrine, Hypotension, Cesarean section, Dose-finding
Brief summary
The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
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. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
Interventions
DRUGNormal saline
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
DRUGNorepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
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 incidence of post-spinal anesthesia hypotension | 1-15 minutes after spinal anesthesia. | Systolic blood pressure (SBP) \< 80% of the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall stability of heart rate control versus baseline | 1-15 minutes after spinal anesthesia. | Evaluated by performance error (PE). |
| 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. |
| Overall stability of systolic blood pressure control versus baseline | 1-15 minutes after spinal anesthesia. | Evaluated by performance error (PE). |
| pH | Immediately after delivery. | From umbilical arterial blood gases. |
| Partial pressure of oxygen | Immediately after delivery. | From umbilical arterial blood gases. |
| 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 |
| The incidence of hypertension. | 1-15 minutes after spinal anesthesia. | Systolic blood pressure (SBP) \>120% of the baseline. |
Countries
China
Outcome results
None listed