Spinal Induced Hypotension
Conditions
Keywords
cesarean section, Bezold-Jarisch reflex, ondansetron
Brief summary
More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death. The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.
Detailed description
Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery. Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.
Interventions
DRUGOndansetron 4 MG
Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia
DRUGOndansetron 8mg
Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia
DRUGEPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution
Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia
OTHER10 mL normal saline
10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study at the level of patients, careproviders, and outcome assessors. Anesthesiologists, surgeons, and operating personnel did not know which study treatment was used. Syringes were identical in terms of volume, color, viscosity, and odor.
Intervention model description
According to patients' randomized groups, study medication was given over 1 min, 5 min before spinal anesthesia Patients were randomly assigned into 1 of 4 groups, using computer generated sequence and opaque envelopes, according to the prophylactic intravenous drug dose used: * Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; * Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; * Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; * Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* age \>18, \<40 years; * American Society of Anesthesiologists physical status I or II; * term pregnancy * singleton pregnancy; * elective cesarean delivery under spinal anesthesia
Exclusion criteria
* Patients with a history of diabetes mellitus other than gestational diabetes, * hypertension, * body mass index \>40 kg/m2, * complicated pregnancy, allergy to study drugs, * long QT syndrome, * Contraindication to spinal anesthesia * Patients who required general anesthesia were withdrawn from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Maternal hypotension | 45 minutes | Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | 5 min after fetal delivery | 1and 5 min after fetal delivery |
Countries
Egypt
Outcome results
None listed