Trial Outcomes & Findings for Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery (NCT NCT02354833)

NCT ID: NCT02354833

Last Updated: 2017-01-04

Results Overview

Number of rescue boluses to maintain the SBP within 100-120% of baseline

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 85 participants
• Primary outcome timeframe: At time of surgery, up to 2 hours
• Results posted on: 2017-01-04

Participant Flow

Participant milestones

Measure	Phenylephrine A continuous phenylephrine infusion at 0.1 mcg/kg/min Phenylephrine	Norepinephrine A continuous norepinephrine infusion at 0.05 mcg/kg/min Norepinephrine
Overall Study STARTED	38	43
Overall Study COMPLETED	38	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery

Baseline characteristics by cohort

Measure	Phenylephrine n=38 Participants A continuous phenylephrine infusion at 0.1 mcg/kg/min Phenylephrine	Norepinephrine n=43 Participants A continuous norepinephrine infusion at 0.05 mcg/kg/min Norepinephrine	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=93 Participants	43 Participants n=4 Participants	81 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 5.6 • n=93 Participants	31.2 years STANDARD_DEVIATION 6.8 • n=4 Participants	30.15 years STANDARD_DEVIATION 6.2 • n=27 Participants
Gender Female	38 Participants n=93 Participants	43 Participants n=4 Participants	81 Participants n=27 Participants
Gender Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	38 participants n=93 Participants	43 participants n=4 Participants	81 participants n=27 Participants

PRIMARY outcome

Timeframe: At time of surgery, up to 2 hours

Number of rescue boluses to maintain the SBP within 100-120% of baseline

Outcome measures

Measure	Phenylephrine n=38 Participants A continuous phenylephrine infusion at 0.1 mcg/kg/min Phenylephrine	Norepinephrine n=43 Participants A continuous norepinephrine infusion at 0.05 mcg/kg/min Norepinephrine
Number of Rescue Boluses to Maintain SBP	25 rescue boluses	21 rescue boluses

PRIMARY outcome

Timeframe: At time of surgery, up to 2 hours

Outcome measures

Measure	Phenylephrine n=38 Participants A continuous phenylephrine infusion at 0.1 mcg/kg/min Phenylephrine	Norepinephrine n=43 Participants A continuous norepinephrine infusion at 0.05 mcg/kg/min Norepinephrine
Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP	0 mg Interval 0.0 to 85.0	0 mg Interval 0.0 to 30.0

PRIMARY outcome

Timeframe: At time of surgery, up to 2 hours

Outcome measures

Measure	Phenylephrine n=38 Participants A continuous phenylephrine infusion at 0.1 mcg/kg/min Phenylephrine	Norepinephrine n=43 Participants A continuous norepinephrine infusion at 0.05 mcg/kg/min Norepinephrine
Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP	50 mcg Interval 0.0 to 1000.0	100 mcg Interval 0.0 to 700.0

SECONDARY outcome

Timeframe: At time of surgery, up to 2 hours

Outcome measures

Measure	Phenylephrine n=38 Participants A continuous phenylephrine infusion at 0.1 mcg/kg/min Phenylephrine	Norepinephrine n=43 Participants A continuous norepinephrine infusion at 0.05 mcg/kg/min Norepinephrine
Percentage of Participants Experiencing Both Nausea and Emesis Percentage of participants with Nausea	63.2 percentage of participants Interval 47.9 to 78.5	51.2 percentage of participants Interval 36.3 to 66.1
Percentage of Participants Experiencing Both Nausea and Emesis Percentage of participants with Emesis	26.3 percentage of participants Interval 12.3 to 40.3	16.3 percentage of participants Interval 5.3 to 27.3

Adverse Events

Phenylephrine

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Norepinephrine

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Phenylephrine n=38 participants at risk Hypotension requiring a rescue bolus	Norepinephrine n=43 participants at risk Hypotension requiring a rescue bolus
Gastrointestinal disorders Nausea	63.2% 24/38 • Number of events 24	51.2% 22/43 • Number of events 22

Additional Information

Dr. Manuel C. Vallejo, Chair of Department of Anesthesiology

West Virginia University

Phone: 304-598-4929

Email: mvallejo@wvumediciane.org

Results disclosure agreements

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