Trial Outcomes & Findings for Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection (NCT NCT06112353)
NCT ID: NCT06112353
Last Updated: 2026-08-25
Results Overview
GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
COMPLETED
PHASE4
132 participants
Post-surgically until report of first bowel movement
2026-08-25
Participant Flow
Patients at UCI Medical Center were assessed for eligibility from April 17, 2024 to March 4, 2026. Patients were screened for inclusion between 48 hours and 10 days prior to the scheduled procedure. Potential study participants were contacted by phone during this period and were informed about the study procedures, risks, and objectives. Patients who expressed interest in participation were approached in the preoperative area on the day of surgery to obtain formal written consent.
Participant milestones
| Measure |
Sugammadex
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
|
Overall Study
COMPLETED
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection
Baseline characteristics by cohort
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=31 Participants
|
63 years
n=49 Participants
|
62 years
n=80 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=31 Participants
|
38 Participants
n=49 Participants
|
71 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=31 Participants
|
28 Participants
n=49 Participants
|
61 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=31 Participants
|
48 Participants
n=49 Participants
|
91 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
10 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=31 Participants
|
10 Participants
n=49 Participants
|
24 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=31 Participants
|
55 Participants
n=49 Participants
|
100 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
|
Height
|
167.6 cm
n=31 Participants
|
167.6 cm
n=49 Participants
|
167.6 cm
n=80 Participants
|
|
Body Mass Index
|
27.8 kg/m^2
n=31 Participants
|
26.1 kg/m^2
n=49 Participants
|
27.17 kg/m^2
n=80 Participants
|
|
Weight
|
85.7 kg
n=31 Participants
|
77.5 kg
n=49 Participants
|
80.3 kg
n=80 Participants
|
|
Comorbidities
Coronary artery bypass graft
|
2 Participants
n=31 Participants
|
7 Participants
n=49 Participants
|
9 Participants
n=80 Participants
|
|
Comorbidities
Congestive heart failure
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
|
Comorbidities
Hypertension
|
42 Participants
n=31 Participants
|
32 Participants
n=49 Participants
|
74 Participants
n=80 Participants
|
|
Comorbidities
Asthma
|
8 Participants
n=31 Participants
|
14 Participants
n=49 Participants
|
22 Participants
n=80 Participants
|
|
Surgery Type
Partial colectomy
|
63 Participants
n=31 Participants
|
62 Participants
n=49 Participants
|
125 Participants
n=80 Participants
|
|
Surgery Type
Ostomy closure
|
3 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Surgery Type
Other
|
0 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
|
Bowel adhesions
|
29 Participants
n=31 Participants
|
29 Participants
n=49 Participants
|
58 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Post-surgically until report of first bowel movementGI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
GI-2 Recovery
|
44.8 hours
Interval 28.2 to 68.0
|
38.3 hours
Interval 25.5 to 48.3
|
SECONDARY outcome
Timeframe: From hospital admission to dischargeTotal cost of surgical stay
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Cost of Stay
|
23,620 USD
|
23,240 USD
|
SECONDARY outcome
Timeframe: From hospital admission to dischargeTotal time patient is at hospital
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Length of Stay
|
3 days
Interval 2.0 to 4.0
|
3 days
Interval 2.3 to 5.0
|
SECONDARY outcome
Timeframe: Up to 30 days post surgeryMorbidity was defined as the number of participants with at least one predefined postoperative complication, including postoperative ileus, pulmonary complications, cardiovascular complications, surgical site infection, urinary tract infection, acute kidney injury, thromboembolic events, reoperation, anastomotic leak, wound dehiscence, or postoperative transfusion within 30 days after surgery. Mortality was defined as all-cause death occurring within 30 days after surgery. Complications were identified through review of the electronic medical record.
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Morbidity & Mortality
Postoperative morbidity
|
7 Participants
|
14 Participants
|
|
Morbidity & Mortality
Postoperative mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post surgically but prior to PACU discharge, up to 24 hoursNumber of participants experiencing post-reversal bradycardia prior to discharge from PACU
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Post Reversal Bradycardia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From surgical end time to PACU discharge, up to 24 hoursTime in PACU, not owing to bed availability. Defined as time to achieve a sustained Aldrete score ≥8.
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Duration of PACU Stay
|
0.52 hours
Interval 0.3 to 0.8
|
0.6 hours
Interval 0.4 to 0.8
|
SECONDARY outcome
Timeframe: Up to 24 hours post surgeryTime for patient to be able to get out of bed and walk post surgically
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Time to Out of Bed
|
17.7 hours
Interval 9.6 to 24.9
|
18.3 hours
Interval 8.6 to 24.0
|
SECONDARY outcome
Timeframe: Intraoperative and postoperative including PACU stay, up to 24 hoursTotal amount of IV fluids administered during and after surgery through PACU stay.
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Amount of Fluid Administration
|
1100 mL
Interval 900.0 to 1800.0
|
1250 mL
Interval 925.0 to 1500.0
|
SECONDARY outcome
Timeframe: Postoperative to discharge, up to 1 weekNumber of Participants Experiencing PONV
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Postoperative Nausea and Vomiting
|
14 Participants
|
15 Participants
|
POST_HOC outcome
Timeframe: IntraoperativeOpen-label sugammadex exposure includes patients who received rescue sugammadex after the blinded study medication administration and patients who received open-label sugammadex as the sole agent used for antagonism of neuromuscular blockade.
Outcome measures
| Measure |
Sugammadex
n=66 Participants
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 Participants
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Open-Label Sugammadex Exposure
|
5 Participants
|
13 Participants
|
Adverse Events
Sugammadex
Neostigmine Plus Glycopyrrolate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugammadex
n=66 participants at risk
2.0 mg/kg of Sugammadex plus saline equivalent
2 syringes numbered 1 and 2
1. Syringe #1: 0.9% sodium chloride
2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)
|
Neostigmine Plus Glycopyrrolate
n=66 participants at risk
0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate
2 syringes numbered 1 and 2
1. Syringe #1: Glycopyrrolate
2. Syringe #2: Neostigmine
|
|---|---|---|
|
Gastrointestinal disorders
Postoperative ileus
|
10.6%
7/66 • From study drug administration to discharge, up to 30 days
|
19.7%
13/66 • From study drug administration to discharge, up to 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place