Ephedrine Versus Ondansetron During Cesarean Delivery
Condition: Spinal Induced Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Ondansetron 4 MG; Ondansetron 8mg; EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution; 10 mL normal saline
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia; Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia; Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia; 10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia
Other intervention name(s): Low dose ondansetron group; Higher dose Ondanseteron group; Ephedrine group; Placebo group
Intervention MeSH terms: Ephedrine; Pseudoephedrine; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cesarean section; Bezold-Jarisch reflex; ondansetron