ClinicalTrialsFinder
RecruitingPhase 4ACTRN12616000884404

Maternal hypotension during elective caesarean delivery under various spinal anaesthesia regimens

The incidence of maternal hypotension during elective caesarean delivery under spinal anesthesia in healthy ASA I pregnant women: comparison of intravenous ondansetron, continuous infusion of phenylephrine and ondansetron plus continuous infusion of phenylephrine with placebo. A double blind, randomized, placebo controlled trial.

Sponsor

University Hospital Gregorio Maranon

Enrollment

280 participants

Start Date

Jul 3, 2017

Study Type

Interventional

Conditions

Maternal pulmonary aspirationMaternal arrythmiasMaternal unconsciousnessMaternal nausea and vomitingMaternal dizzinessFetal acidosismaternal hypotension during elective caesarean delivery under spinal anaesthesia

Summary

Background: Spinal anesthesia for caesarean delivery is frequently associated with maternal hypotension. The sitting position for spinal anesthesia and prophylactic administrations of ondansetron or phenylephrine have been reported to provide a protective effect. We studied the effect of ondansetron or ondansetron + phenylephrine in obstetric patients. Methods: This prospective double-blind, randomised, placebo-controlled study includes healthy pregnant women scheduled for elective caesarean delivery under spinal anesthesia. Women will be randomly allocated into four groups to receive either placebo, ondansetron 8 mg intravenously before induction of spinal anesthesia, phenylephrine infusion (50 mcg/min) or ondansetron plus phenylephrine infusion (50 mcg/min). Demographic, obstetric, intraoperative timing and anaesthetic variables will be assessed at 16 time points. Anesthetic variables assessed will include blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus and vasopressor requirements. Study hypothesis: the combination of ondansetron plus phenylephrine infusion can help to reduce the incidence and severity of maternal hypotension compared with placebo, ondansetron or phenylephrine infusion.

Eligibility

Sex: FemalesMin Age: 20 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing different combinations of medications to prevent a dangerous drop in blood pressure (hypotension) that commonly occurs during spinal anaesthesia for a planned caesarean section. The four options being compared are: a placebo, ondansetron (a nausea drug), a continuous infusion of phenylephrine (a blood pressure drug), and a combination of both ondansetron and phenylephrine. Researchers want to find the most effective way to keep the mother's blood pressure stable during the operation. You may be eligible if: - You are a woman between 20 and 45 years old - You are scheduled for an elective (planned) caesarean section under spinal anaesthesia - You are classified as ASA (American Society of Anesthesiologists) physical status class 1 (healthy) - Your BMI at delivery is 30 or less - You are able to give written informed consent You may NOT be eligible if: - You refused to participate - You have a contraindication to spinal anaesthesia - You are under 20 or over 45 years old - Your BMI exceeds 30 kg/m2 at the time of surgery - You have previously received intravenous fluids before the procedure - You have a known allergy or reaction to ondansetron or phenylephrine Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your DoctorCheck Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The syringes have no identifying markers indicating group allocation. The nurse injects the contents of the 10 mL syringe intravenously over 60 s and starts the 50 mL syringe IV continuous infusion at

The syringes have no identifying markers indicating group allocation. The nurse injects the contents of the 10 mL syringe intravenously over 60 s and starts the 50 mL syringe IV continuous infusion at 15 mL/h five minutes before the lumbar puncture is performed. The anaesthetist caring for the woman is blinded to group allocation. Arm 1: ondansetron 8 mg with 0.9% saline solution (total volume 10 mL) intravenously over 60 s AND phenylephrine 10 mg with 0.9% saline solution to a total volume of 49 mL (50 mcg/min continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia Arm 2: placebo of 0.9% saline solution 10 mL (administered intravenously over 60 s) AND phenylephrine 10 mg with 0.9% saline solution to a total volume of 49 mL (50 mcg/min continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia. Arm 3: ondansetron 8 mg with 0.9% saline solution (total volume 10 mL, administered intravenously over 60 s), AND 0.9% saline solution 50 mL (continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia. Arm 4: placebo of 0.9% saline solution 10 mL (administered intravenously over 60 s) AND 0.9% saline solution 50 mL (continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia. The duration of the continuous infusion for all arms is until end of procedure.

Locations(1)

Madrid, Spain

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12616000884404