Trial Outcomes & Findings for Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section? (NCT NCT02369510)
NCT ID: NCT02369510
Last Updated: 2017-08-30
Results Overview
Time to T10 sensory recovery as measured by pinprick sensation
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
up to 3 hours
Results posted on
2017-08-30
Participant Flow
Participant milestones
| Measure |
Low-dose Epinephrine
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
23
|
|
Overall Study
COMPLETED
|
21
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
Low-dose Epinephrine
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Overall Study
Spilled Medication
|
1
|
2
|
1
|
|
Overall Study
Epidural Activation
|
1
|
1
|
5
|
Baseline Characteristics
Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
Baseline characteristics by cohort
| Measure |
Low-dose Epinephrine
n=23 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=22 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=23 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 3.86 • n=93 Participants
|
34 years
STANDARD_DEVIATION 5.19 • n=4 Participants
|
34 years
STANDARD_DEVIATION 5.12 • n=27 Participants
|
34 years
STANDARD_DEVIATION 4.73 • n=483 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Pre-op Systolic Blood Pressure (SBP)
|
116 mmHg
STANDARD_DEVIATION 12 • n=93 Participants
|
119 mmHg
STANDARD_DEVIATION 10 • n=4 Participants
|
115 mmHg
STANDARD_DEVIATION 11 • n=27 Participants
|
117 mmHg
STANDARD_DEVIATION 11 • n=483 Participants
|
|
Pre-op Diastolic Blood Pressure (DBP)
|
70 mmHg
STANDARD_DEVIATION 11 • n=93 Participants
|
70 mmHg
STANDARD_DEVIATION 9 • n=4 Participants
|
66 mmHg
STANDARD_DEVIATION 8 • n=27 Participants
|
70 mmHg
STANDARD_DEVIATION 10 • n=483 Participants
|
|
Pre-op Heart Rate (HR)
|
82 beats per minute
STANDARD_DEVIATION 10 • n=93 Participants
|
85 beats per minute
STANDARD_DEVIATION 9 • n=4 Participants
|
78 beats per minute
STANDARD_DEVIATION 10 • n=27 Participants
|
82 beats per minute
STANDARD_DEVIATION 10 • n=483 Participants
|
PRIMARY outcome
Timeframe: up to 3 hoursTime to T10 sensory recovery as measured by pinprick sensation
Outcome measures
| Measure |
Low-dose Epinephrine
n=21 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=19 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=17 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Sensory Recovery
|
135 minutes
Interval 120.0 to 150.0
|
165 minutes
Interval 150.0 to 180.0
|
120 minutes
Interval 45.0 to 150.0
|
SECONDARY outcome
Timeframe: up to 4 hoursTime to Bromage 3 motor recovery
Outcome measures
| Measure |
Low-dose Epinephrine
n=21 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=19 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=17 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Motor Recovery
|
150 minutes
Interval 135.0 to 150.0
|
172 minutes
Interval 150.0 to 210.0
|
120 minutes
Interval 105.0 to 120.0
|
SECONDARY outcome
Timeframe: up to 15 minTime to a onset of T4 level of anesthesia or the highest level achieved in 15min
Outcome measures
| Measure |
Low-dose Epinephrine
n=21 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=19 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=17 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Block Onset
|
6 minutes
Interval 6.0 to 8.0
|
8 minutes
Interval 6.0 to 8.0
|
8 minutes
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: at 2 minutes and at 25 minutesIncidence of hypotension as measured by participants needing vasopressor agents
Outcome measures
| Measure |
Low-dose Epinephrine
n=21 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=19 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=17 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Number of Participants With Hypotension
2 minutes
|
5 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants With Hypotension
25 minutes
|
3 Participants
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 3 hrsAs measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia.
Outcome measures
| Measure |
Low-dose Epinephrine
n=21 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=19 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=17 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Adequacy of Anesthesia
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: up to 3 hoursPatient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or "completely satisfied".
Outcome measures
| Measure |
Low-dose Epinephrine
n=21 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=19 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=17 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Patient Satisfaction
|
90 percentage of participants
|
85 percentage of participants
|
87 percentage of participants
|
SECONDARY outcome
Timeframe: up to 3 hoursOutcome measures
| Measure |
Low-dose Epinephrine
n=21 Participants
100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
High-dose Epinephrine
n=19 Participants
200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
|
No Epinephrine
n=17 Participants
0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications
|
|---|---|---|---|
|
Incidence of Nausea and Vomiting
2 minutes
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Incidence of Nausea and Vomiting
25 minutes
|
3 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 3 hoursdata not collected
Outcome measures
Outcome data not reported
Adverse Events
Low-dose Epinephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-dose Epinephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Epinephrine
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
Dr. Daniel Katz
Icahn School of Medicine at Mount Sinai
Phone: 212-241-7475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place