Trial Outcomes & Findings for Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section (NCT NCT00432991)

Results Overview

Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

immediately pre-induction

Results posted on

2017-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Saline Placebo Saline Placebo: 0.5 mL, IM (in the muscle), one time	IM Ephedrine IM Ephedrine Ephedrine \[Synonyms: Ephedra, Ephedrinum\]: 25 mg, IM (in the muscle), one time
Overall Study STARTED	22	31
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	7	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Saline Placebo Saline Placebo: 0.5 mL, IM (in the muscle), one time	IM Ephedrine IM Ephedrine Ephedrine \[Synonyms: Ephedra, Ephedrinum\]: 25 mg, IM (in the muscle), one time
Overall Study Protocol Violation	7	12

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline Placebo n=15 Participants Saline Placebo: 0.5 mL, IM (in the muscle), one time	IM Ephedrine n=19 Participants IM Ephedrine Ephedrine \[Synonyms: Ephedra, Ephedrinum\]: 25 mg, IM (in the muscle), one time	Total n=34 Participants Total of all reporting groups
Age, Continuous	34.1 years STANDARD_DEVIATION 4.64 • n=15 Participants	33.4 years STANDARD_DEVIATION 4.4 • n=19 Participants	33.7 years STANDARD_DEVIATION 4.45 • n=34 Participants
Sex: Female, Male Female	15 Participants n=15 Participants	19 Participants n=19 Participants	34 Participants n=34 Participants
Sex: Female, Male Male	0 Participants n=15 Participants	0 Participants n=19 Participants	0 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: immediately pre-induction

Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea

Outcome measures

Outcome measures
Measure	Saline Placebo n=15 Participants Saline Placebo: 0.5 mL, IM (in the muscle), one time	IM Ephedrine n=19 Participants IM Ephedrine Ephedrine \[Synonyms: Ephedra, Ephedrinum\]: 25 mg, IM (in the muscle), one time
Pre-Induction Nausea Score	0.067 units on a scale Standard Deviation 0.26	0 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: intra-operation

Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin. The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject.

Outcome measures

Outcome measures
Measure	Saline Placebo n=15 Participants Saline Placebo: 0.5 mL, IM (in the muscle), one time	IM Ephedrine n=19 Participants IM Ephedrine Ephedrine \[Synonyms: Ephedra, Ephedrinum\]: 25 mg, IM (in the muscle), one time
Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea.	0.16 units on a scale Standard Deviation 0.32	0.28 units on a scale Standard Deviation 0.34

PRIMARY outcome

Timeframe: post-operation

Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU. The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject.

Outcome measures

Outcome measures
Measure	Saline Placebo n=15 Participants Saline Placebo: 0.5 mL, IM (in the muscle), one time	IM Ephedrine n=19 Participants IM Ephedrine Ephedrine \[Synonyms: Ephedra, Ephedrinum\]: 25 mg, IM (in the muscle), one time
Post-Operation Nausea Score	0.067 units on a scale Standard Deviation 0.26	0.53 units on a scale Standard Deviation 0.77

Adverse Events

Saline Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

IM Ephedrine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Saline Placebo n=22 participants at risk Saline Placebo: 0.5 mL, IM (in the muscle), one time	IM Ephedrine n=31 participants at risk IM Ephedrine Ephedrine \[Synonyms: Ephedra, Ephedrinum\]: 25 mg, IM (in the muscle), one time
General disorders Lightheadedness	4.5% 1/22 • Number of events 1	0.00% 0/31
General disorders Pruritis	9.1% 2/22 • Number of events 2	6.5% 2/31 • Number of events 2

Additional Information

Michele Steinkamp, Research Nurse Specialist

Weill Cornell Medicine, Department of Anesthesiology

Phone: 212-746-2953

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place