Adverse Effect
Conditions
Keywords
Crystalloid, Hydroxyethyl starch 130/0.4, Postspinal anesthesia hypotension, Cesarean section, Norepinephrine, Coload
Brief summary
The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients 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. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, 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 ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
Interventions
10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
DRUGCrystalloid
10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
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 * Coagulation or renal function disorders * Known allergy to hydroxyethyl starch * Fetal distress, or known fetal developmental anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ED 50 and ED 90 | 1-15 minutes after spinal anesthesia | The dose of prophylactic norepinephrine combined with 10 ml/kg 6% Hydroxyethyl starch (130/0.4) or 10 ml/kg crystalloid coload that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients |
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 bradycardia. | 1-15 minutes after spinal anesthesia | Heart rate \< 60 beats/min. |
| 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 hypertension. | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \>120% of the baseline. |
| The incidence of post-spinal anesthesia hypotension | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \< 80% of the baseline |
| Partial pressure of oxygen (PO2) | Immediately after delivery | From umbilical arterial blood gases. |
| Base excess (BE) | Immediately after delivery | From umbilical arterial blood gases. |
| APGAR score | 1 min after delivery | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration |
| pH | Immediately after delivery | From umbilical arterial blood gases. |
Countries
China
Outcome results
None listed