Trial Outcomes & Findings for Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections (NCT NCT01734161)
NCT ID: NCT01734161
Last Updated: 2019-10-15
Results Overview
The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome timeframe
48 hours
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Dexamethasone
One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given
|
Placebo
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
55
|
53
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections
Baseline characteristics by cohort
| Measure |
Dexamethasone
n=55 Participants
One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given
|
Placebo
n=53 Participants
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
35.7 years
STANDARD_DEVIATION 3.7 • n=107 Participants
|
35.5 years
STANDARD_DEVIATION 4.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hoursThe patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery
Outcome measures
| Measure |
Dexamethasone
n=55 Participants
One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given
|
Placebo
n=53 Participants
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline
|
|---|---|---|
|
Incidence of Post-operative Nausea and/or Vomiting
|
29 Participants
|
24 Participants
|
Adverse Events
Dexamethasone
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone
n=55 participants at risk
One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given
|
Placebo
n=53 participants at risk
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline
|
|---|---|---|
|
Vascular disorders
Hypertension
|
1.8%
1/55 • Number of events 1
|
5.7%
3/53 • Number of events 3
|
|
Surgical and medical procedures
incision site bleeding
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
General disorders
low body temperature
|
3.6%
2/55 • Number of events 2
|
0.00%
0/53
|
|
General disorders
post-op shivering
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Cardiac disorders
Tachycardia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Vascular disorders
Transfusion Required
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place