ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000884404

Ethics application status

Approved

Date submitted

5/06/2016

Date registered

5/07/2016

Date last updated

26/07/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Maternal hypotension during elective caesarean delivery under various spinal anaesthesia regimens

Scientific title

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.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

maternal hypotension during elective caesarean delivery under spinal anaesthesia

Maternal nausea and vomiting

Maternal dizziness

Maternal unconsciousness

Maternal pulmonary aspiration

Maternal arrythmias

Fetal acidosis

Condition category

Condition code

Anaesthesiology

Anaesthetics

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

It is very important to state that the control group (placebo) will receive all standardized cares internationally accepted for an elective cesarean delivery under spinal anesthesia. The other 3 groups, ondansetron, phenylephrine or ondansetron + phenylephrine are not an usual practice for all obstetric anesthesiologists, but the doses proposed in this study are accepted as the usual doses of these drugs for cesarean delivery under spinal anesthesia

Control group

Placebo

Outcomes

Primary outcome [1]

The primary outcome, hypotension, is defined in this study as a systolic blood pressure <75% of baseline, using the criteria outlined in the Cochrane review of hypotension in obstetrics.
Systolic blood pressure will be assessed using electronic noninvasive blood pressure monitor with readings displayed on the monitoring screen

Timepoint [1]

Systolic blood pressure will be recorded before administration of the study drug and the at 2 min intervals for 15 min and 5 min intervals for a further 30 min after intrathecal injection, as well as at the end of surgery.

Secondary outcome [1]

diastolic blood pressure, measured with non invasive blood pressure monitor with readings displayed on the monitoring screen

Timepoint [1]