Trial Outcomes & Findings for The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries (NCT NCT01841606)

NCT ID: NCT01841606

Last Updated: 2018-05-11

Results Overview

Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 57 participants
• Primary outcome timeframe: Baseline and 20 minutes
• Results posted on: 2018-05-11

Participant Flow

Participant milestones

Measure	Ondansetron Patients receiving pre-spinal ondansetron	Placebo Patients receiving placebo
Overall Study STARTED	25	27
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

Baseline characteristics by cohort

Measure	Ondansetron n=25 Participants 4mg IV Ondansetron	Placebo n=27 Participants 10mL IV normal saline	Total n=52 Participants Total of all reporting groups
Age, Continuous	34.32 years STANDARD_DEVIATION 3.86 • n=5 Participants	34.7 years STANDARD_DEVIATION 4.76 • n=7 Participants	34.5 years STANDARD_DEVIATION 4.27 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	25 participants n=5 Participants	27 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 20 minutes

Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)

Outcome measures

Measure	Ondansetron n=25 Participants Patients receiving pre-spinal ondansetron	Placebo n=27 Participants Patients receiving placebo
Change in Cardiac Output From Baseline to 20 Minutes Post-spinal	-2.05 L/min Standard Deviation 1.43	-1.92 L/min Standard Deviation 1.41

Adverse Events

Ondansetron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr. James Taylor

UBC Department of Anesthesia - BC Women's Hospital

Phone: 604-875-2424

Email: james.taylor1@phsa.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place