Trial Outcomes & Findings for Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy (NCT NCT05256901)
NCT ID: NCT05256901
Last Updated: 2025-09-30
Results Overview
The time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Up to 2 hours
Results posted on
2025-09-30
Participant Flow
Participant milestones
| Measure |
Sugammadex
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy
Baseline characteristics by cohort
| Measure |
Sugammadex
n=11 Participants
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
n=11 Participants
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.55 years
STANDARD_DEVIATION 3.50 • n=5 Participants
|
10.18 years
STANDARD_DEVIATION 3.52 • n=7 Participants
|
11.37 years
STANDARD_DEVIATION 3.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hoursThe time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital.
Outcome measures
| Measure |
Sugammadex
n=11 Participants
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
n=11 Participants
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
|---|---|---|
|
Total Time From Surgery End to Out of the Operating Room (OR)
|
9.55 minutes
Standard Deviation 3.03
|
10.82 minutes
Standard Deviation 4.87
|
SECONDARY outcome
Timeframe: Up to 48 hoursTime to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital
Outcome measures
| Measure |
Sugammadex
n=11 Participants
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
n=11 Participants
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
|---|---|---|
|
Total Time to First Bowel Movement
|
18.4 hours
Standard Deviation 6.7
|
23.78 hours
Standard Deviation 16.74
|
SECONDARY outcome
Timeframe: Up to 24 hoursThe research team will evaluate via the Epic computer record after discharge from the hospital
Outcome measures
| Measure |
Sugammadex
n=11 Participants
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
n=11 Participants
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
|---|---|---|
|
Total Time to Tolerance of an Oral Diet
|
4.3 hours
Standard Deviation 1.96
|
8.05 hours
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: Up to 5 hours (depending on length of surgical procedure)evaluated via the Epic computer record after discharge from the hospital
Outcome measures
| Measure |
Sugammadex
n=11 Participants
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
n=11 Participants
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
|---|---|---|
|
Total Time of Inhalational Anesthesia Exposure
|
121.30 minutes
Standard Deviation 40.14
|
142.94 minutes
Standard Deviation 34.32
|
SECONDARY outcome
Timeframe: Up to 5 hours (on average depending on post anesthesia recovery)PACU length of stay was evaluated via the Epic computer record after discharge from the hospital
Outcome measures
| Measure |
Sugammadex
n=11 Participants
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
n=11 Participants
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
|---|---|---|
|
Length of Stay in the Post-anesthesia Care Unit (PACU)
|
27.91 minutes
Standard Deviation 9.07
|
37.73 minutes
Standard Deviation 12.65
|
SECONDARY outcome
Timeframe: Up to 5 days (depending on length of hospitalization)Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital
Outcome measures
| Measure |
Sugammadex
n=11 Participants
The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater.
|
Neostigmine/Glycopyrrolate
n=11 Participants
The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
|
|---|---|---|
|
Hospital Length of Stay (LoS)
|
34.64 hours
Standard Deviation 39.07
|
49.51 hours
Standard Deviation 50.56
|
Adverse Events
Sugammadex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Neostigmine/Glycopyrrolate
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
Viola Vaccarino, MD, PhD, Principal Investigator
Emory University
Phone: 404-727-8710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place