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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

132 participants

Primary outcome timeframe

Post-surgically until report of first bowel movement

Results posted on

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

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

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 movement

GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet

Outcome measures

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 discharge

Total cost of surgical stay

Outcome measures

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 discharge

Total time patient is at hospital

Outcome measures

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 surgery

Morbidity 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

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 hours

Number of participants experiencing post-reversal bradycardia prior to discharge from PACU

Outcome measures

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 hours

Time in PACU, not owing to bed availability. Defined as time to achieve a sustained Aldrete score ≥8.

Outcome measures

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 surgery

Time for patient to be able to get out of bed and walk post surgically

Outcome measures

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 hours

Total amount of IV fluids administered during and after surgery through PACU stay.

Outcome measures

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 week

Number of Participants Experiencing PONV

Outcome measures

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: Intraoperative

Open-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

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

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Neostigmine Plus Glycopyrrolate

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Robert Ryan Field, MD

University of California, Irvine

Phone: 7144565501

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place