Intestinal DiseasePhase 4NCT06112353
Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection
A Phase 4 study testing Neostigmine Injectable Solution and Sugammadex injection in people with Intestinal Disease, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Disease
- What is being tested?
- Neostigmine Injectable Solution and Sugammadex injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission
Who cannot join
- Allergy to Rocuronium, Vecuronium, or Sugammadex
- Bowel resection surgery requiring an ostomy
- No severe valvulopathy, no systolic heart failure with reduced ejection fraction (HFrEF), no coronary artery disease with positive stress test for ischemic regional wall motion abnormality
- No autoimmune pulmonary disease, no severe pulmonary fibrosis, no severe pulmonary hypertension, no COPD with requirement of home oxygen, no pulmonary cancer of primary or metastatic origin
- Creatinine Clearance (CrCl) of less than 30
- Pregnancy
- Incapable of providing consent or understanding the research project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sugammadex VS Neostigmine and Glycopyrrolate Reversal of Neuromuscular Relaxation For Time to Return of Bowel Function After Bowel Resection: Prospective, Randomized, Triple-blinded Clinical Trial For Quality Improvement
The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery
Read the detailed description
Neuromuscular blocking agents are essential during surgical procedures to paralyze the body to avoid unnecessary movement during surgery. There are various medications, such as Sugammadex that are later used to reverse the effects of the neuromuscular blockade. The U.S. performs approximately 320,000 colectomies per year for benign and malignant conditions such as Ulcerative Colitis (UC). Bowel resection surgery removes a portion of small or large intestine. Currently, there is little available prospective outcomes data regarding the use of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (hour) to first bowel movement and tolerance for solid food (aka GI-2 recovery) following bowel resection surgery. The study team will be conducting a randomized triple-blind study (patient's assigned group is hidden from the patient, provider, and research team). Randomization is created by using an electronic randomizer. Upon consent, the patient's assignment (per the randomizer) will be submitted to the Investigational Drug Service (IDS) Pharmacy by a department employee with no direct patient interaction.
- Conditions
- Intestinal Disease
- Being tested
- Neostigmine Injectable Solution, Sugammadex injection
- Keywords
- Laparoscopic Bowel Resection, Sugammadex, Neostigmine, Glycopyrrolate, GI-2
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine Injectable SolutionDrug
Also called Neostigmine plus Glycopyrrolate, Group B
Examine GI-2 recovery
Sugammadex injectionDrug
Also called Sugammadex, Group A
Examine GI-2 recovery
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine plus Glycopyrrolate | Active comparator | 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 Receives: Drug: Neostigmine Injectable Solution |
| Sugammadex | Active comparator | 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) Receives: Drug: Sugammadex injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI-2 Recovery
GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
Measured: Post-surgically until report of first bowel movement
Secondary outcomes (8)
Cost of Stay
Total cost of surgical stay
Measured: From hospital admission to discharge
Length of Stay
Total time patient is at hospital
Measured: From hospital admission to discharge
Morbidity & Mortality
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.
Measured: Up to 30 days post surgery
Post Reversal Bradycardia
Number of participants experiencing post-reversal bradycardia prior to discharge from PACU
Measured: Post surgically but prior to PACU discharge, up to 24 hours
Duration of PACU Stay
Time in PACU, not owing to bed availability. Defined as time to achieve a sustained Aldrete score ≥8.
Measured: From surgical end time to PACU discharge, up to 24 hours
Time to Out of Bed
Time for patient to be able to get out of bed and walk post surgically
Measured: Up to 24 hours post surgery
Amount of Fluid Administration
Total amount of IV fluids administered during and after surgery through PACU stay.
Measured: Intraoperative and postoperative including PACU stay, up to 24 hours
Postoperative Nausea and Vomiting
Number of Participants Experiencing PONV
Measured: Postoperative to discharge, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start17 Apr 2024
- Primary completion4 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intestinal DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Robert Ryan Field, University of California, Irvine
- Investigators
- Robert R Field, MD, Principal investigator, Associate Clinical Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112353
- Sponsor's protocol ID
- 2295
- Other IDs
- Field 100931
- Status last verified
- Jul 2026
- First submitted
- 20 Oct 2023
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.
PubMed 28806470Briggs A, Goldberg J. Tips, Tricks, and Technique for Laparoscopic Colectomy. Clin Colon Rectal Surg. 2017 Apr;30(2):130-135. doi: 10.1055/s-0036-1597313.
PubMed 28381944Deyhim N, Beck A, Balk J, Liebl MG. Impact of Sugammadex Versus Neostigmine/Glycopyrrolate on Perioperative Efficiency. Clinicoecon Outcomes Res. 2020 Jan 31;12:69-79. doi: 10.2147/CEOR.S221308. eCollection 2020.
PubMed 32099426Gray PJ, Goldwag JL, Eid MA, Sacks OA, Wilson LR, Wilson MZ, Ivatury SJ. Does Bowel Function Change After Colectomy for Colon Malignancy? J Surg Res. 2021 Feb;258:283-288. doi: 10.1016/j.jss.2020.09.003. Epub 2020 Oct 8.
PubMed 33039637Bhurwal A, Minacapelli CD, Patel A, Mutneja H, Goel A, Shah I, Bansal V, Brahmbhatt B, Das KM. Evaluation of a U.S. National Cohort to Determine Utilization in Colectomy Rates for Ulcerative Colitis Among Ethnicities. Inflamm Bowel Dis. 2022 Jan 5;28(1):54-61. doi: 10.1093/ibd/izab020.
PubMed 33534892Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.
PubMed 19015469Deljou A, Soleimani J, Sprung J, Schroeder DR, Weingarten TN. Effects of Reversal Technique for Neuromuscular Paralysis on Time to Recovery of Bowel Function after Craniotomy. Am Surg. 2023 May;89(5):1605-1609. doi: 10.1177/00031348211058631. Epub 2022 Jan 5.
PubMed 34986061Booij LH, van Egmond J, Driessen JJ, de Boer HD. In vivo animal studies with sugammadex. Anaesthesia. 2009 Mar;64 Suppl 1:38-44. doi: 10.1111/j.1365-2044.2008.05869.x.
PubMed 19222430
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex VS Neostigmine and Glycopyrrolate Reversal of Neuromuscular Relaxation For Time to Return of Bowel Function After Bowel Resection: Prospective, Randomized, Triple-blinded Clinical Trial For Quality Improvement
- ClinicalTrials.gov ID
- NCT06112353
- Acronym / sponsor ID
- 2295
- Conditions
- Intestinal Disease
- Keywords
- Laparoscopic Bowel Resection, Sugammadex, Neostigmine, Glycopyrrolate, GI-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery
Detailed description
Neuromuscular blocking agents are essential during surgical procedures to paralyze the body to avoid unnecessary movement during surgery. There are various medications, such as Sugammadex that are later used to reverse the effects of the neuromuscular blockade. The U.S. performs approximately 320,000 colectomies per year for benign and malignant conditions such as Ulcerative Colitis (UC). Bowel resection surgery removes a portion of small or large intestine. Currently, there is little available prospective outcomes data regarding the use of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (hour) to first bowel movement and tolerance for solid food (aka GI-2 recovery) following bowel resection surgery. The study team will be conducting a randomized triple-blind study (patient's assigned group is hidden from the patient, provider, and research team). Randomization is created by using an electronic randomizer. Upon consent, the patient's assignment (per the randomizer) will be submitted to the Investigational Drug Service (IDS) Pharmacy by a department employee with no direct patient interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine plus Glycopyrrolate | Active comparator | Drug: Neostigmine Injectable Solution0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate 2 syringes numbered 1 and 2 1. Syringe #1: Glycopyrrolate 2. Syringe #2: Neostigmine |
| Sugammadex | Active comparator | Drug: Sugammadex injection2.0 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission
Key exclusion criteria (7 listed)
- Allergy to Rocuronium, Vecuronium, or Sugammadex
- Bowel resection surgery requiring an ostomy
- No severe valvulopathy, no systolic heart failure with reduced ejection fraction (HFrEF), no coronary artery disease with positive stress test for ischemic regional wall motion abnormality
- No autoimmune pulmonary disease, no severe pulmonary fibrosis, no severe pulmonary hypertension, no COPD with requirement of home oxygen, no pulmonary cancer of primary or metastatic origin
- Creatinine Clearance (CrCl) of less than 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine Injectable SolutionAlso: Neostigmine plus Glycopyrrolate, Group BExamine GI-2 recovery | Drug | Neostigmine plus Glycopyrrolate |
| Sugammadex injectionAlso: Sugammadex, Group AExamine GI-2 recovery | Drug | Sugammadex |
Primary outcome
GI-2 Recovery
Time frame: Post-surgically until report of first bowel movement
GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
8 secondary outcomes
Cost of Stay
Time frame: From hospital admission to discharge
Length of Stay
Time frame: From hospital admission to discharge
Morbidity & Mortality
Time frame: Up to 30 days post surgery
Post Reversal Bradycardia
Time frame: Post surgically but prior to PACU discharge, up to 24 hours
Duration of PACU Stay
Time frame: From surgical end time to PACU discharge, up to 24 hours
Time to Out of Bed
Time frame: Up to 24 hours post surgery
Amount of Fluid Administration
Time frame: Intraoperative and postoperative including PACU stay, up to 24 hours
Postoperative Nausea and Vomiting
Time frame: Postoperative to discharge, up to 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28806470Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.
- Background: PubMed 28381944Briggs A, Goldberg J. Tips, Tricks, and Technique for Laparoscopic Colectomy. Clin Colon Rectal Surg. 2017 Apr;30(2):130-135. doi: 10.1055/s-0036-1597313.
- Background: PubMed 32099426Deyhim N, Beck A, Balk J, Liebl MG. Impact of Sugammadex Versus Neostigmine/Glycopyrrolate on Perioperative Efficiency. Clinicoecon Outcomes Res. 2020 Jan 31;12:69-79. doi: 10.2147/CEOR.S221308. eCollection 2020.
- Background: PubMed 33039637Gray PJ, Goldwag JL, Eid MA, Sacks OA, Wilson LR, Wilson MZ, Ivatury SJ. Does Bowel Function Change After Colectomy for Colon Malignancy? J Surg Res. 2021 Feb;258:283-288. doi: 10.1016/j.jss.2020.09.003. Epub 2020 Oct 8.
- Background: PubMed 33534892Bhurwal A, Minacapelli CD, Patel A, Mutneja H, Goel A, Shah I, Bansal V, Brahmbhatt B, Das KM. Evaluation of a U.S. National Cohort to Determine Utilization in Colectomy Rates for Ulcerative Colitis Among Ethnicities. Inflamm Bowel Dis. 2022 Jan 5;28(1):54-61. doi: 10.1093/ibd/izab020.
- Background: PubMed 19015469Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.
- Background: PubMed 34986061Deljou A, Soleimani J, Sprung J, Schroeder DR, Weingarten TN. Effects of Reversal Technique for Neuromuscular Paralysis on Time to Recovery of Bowel Function after Craniotomy. Am Surg. 2023 May;89(5):1605-1609. doi: 10.1177/00031348211058631. Epub 2022 Jan 5.
- Background: PubMed 19222430Booij LH, van Egmond J, Driessen JJ, de Boer HD. In vivo animal studies with sugammadex. Anaesthesia. 2009 Mar;64 Suppl 1:38-44. doi: 10.1111/j.1365-2044.2008.05869.x.
- Individual participant dataSharing planned: No
Related trials for Intestinal Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert R Field, MD principal investigator
Associate Clinical Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neostigmine Injectable Solution and Sugammadex injection in people with Intestinal Disease, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI-2 Recovery (time frame: Post-surgically until report of first bowel movement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06112353, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.