Adverse Effect
Conditions
Keywords
Ondansetron, Coload, Hypotension, Cesarean section
Brief summary
The purpose of this study is to investigate the effectiveness of ondansetron 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. Ondansetron have been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.
Interventions
DRUGnormal saline
A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.
DRUGOndansetron 4 mg
A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.
DRUGOndansetron 8 mg
A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 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 |
|---|---|---|
| Overall stability of systolic blood pressure control versus baseline | 1-15 minutes after spinal anesthesia | Evaluated by performance error (PE) |
| 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 |
|---|---|---|
| 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. |
| 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. |
| Base excess | 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. |
| The incidence of severe post-spinal anesthesia hypotension | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \< 60% of the baseline |
Countries
China
Outcome results
None listed