Trial Outcomes & Findings for Prevention of Intraoperative Nausea and Vomiting During Cesarean Section (NCT NCT01216410)

NCT ID: NCT01216410

Last Updated: 2014-08-06

Results Overview

Comparison of intraoperative nausea and vomiting between the 3 groups.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 306 participants
• Primary outcome timeframe: Intraoperatively
• Results posted on: 2014-08-06

Participant Flow

December 2008-January 2011, University Medical Center

Participant milestones

Measure	Combination Group Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis	Metoclopramide Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal	Phenylephrine Infusion Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal
Overall Study STARTED	103	100	103
Overall Study COMPLETED	101	99	100
Overall Study NOT COMPLETED	2	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Baseline characteristics by cohort

Measure	Combination Group n=103 Participants Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis	Metoclopramide n=100 Participants Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal	Phenylephrine Infusion n=103 Participants Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal	Total n=306 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=5 Participants	100 Participants n=7 Participants	103 Participants n=5 Participants	306 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	31 years STANDARD_DEVIATION 6 • n=5 Participants	31 years STANDARD_DEVIATION 5 • n=7 Participants	32 years STANDARD_DEVIATION 6 • n=5 Participants	31 years STANDARD_DEVIATION 6 • n=4 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	100 Participants n=7 Participants	103 Participants n=5 Participants	306 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	55 participants n=5 Participants	52 participants n=7 Participants	58 participants n=5 Participants	165 participants n=4 Participants
Region of Enrollment Canada	48 participants n=5 Participants	48 participants n=7 Participants	45 participants n=5 Participants	141 participants n=4 Participants

PRIMARY outcome

Timeframe: Intraoperatively

Comparison of intraoperative nausea and vomiting between the 3 groups.

Outcome measures

Measure	Combination Group n=101 Participants Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis	Metoclopramide n=100 Participants Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal	Phenylephrine Infusion n=99 Participants Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal
Intraoperative Nausea and Vomiting	23 participants	31 participants	49 participants

SECONDARY outcome

Timeframe: 0-2h, 2-6h, 6-24h

Outcome measures

Measure	Combination Group n=101 Participants Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis	Metoclopramide n=99 Participants Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal	Phenylephrine Infusion n=100 Participants Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal
Postoperative Nausea and Vomiting (PONV) 0-2 hrs PONV	20 participants	33 participants	39 participants
Postoperative Nausea and Vomiting (PONV) 2-6 hrs PONV	28 participants	35 participants	41 participants
Postoperative Nausea and Vomiting (PONV) 6-24 hrs PONV	22 participants	26 participants	22 participants

SECONDARY outcome

Timeframe: 0-24 hrs

Outcome measures

Measure	Combination Group n=101 Participants Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis	Metoclopramide n=99 Participants Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal	Phenylephrine Infusion n=100 Participants Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal
Pruritus	95 participants	93 participants	97 participants

SECONDARY outcome

Timeframe: 24 h

1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.

Outcome measures

Measure	Combination Group n=101 Participants Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis	Metoclopramide n=99 Participants Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal	Phenylephrine Infusion n=100 Participants Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal
Satisfaction	94 participants	85 participants	87 participants

SECONDARY outcome

Timeframe: Intraoperatively

The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively

Outcome measures

Measure	Combination Group n=101 Participants Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis	Metoclopramide n=99 Participants Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal	Phenylephrine Infusion n=100 Participants Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal
Maternal Hemodynamics	16 participants with SBP< 20 % baseline	19 participants with SBP< 20 % baseline	16 participants with SBP< 20 % baseline

Adverse Events

Combination Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phenylephrine Infusion

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

Ashraf Habib

Duke University Medical Center

Phone: 919 668 6266

Email: habib001@dm.duke.edu

Results disclosure agreements

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