Intestinal Disease
Conditions
Keywords
Laparoscopic Bowel Resection, Sugammadex, Neostigmine, Glycopyrrolate, GI-2
Brief 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
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.
Interventions
DRUGNeostigmine Injectable Solution
Examine GI-2 recovery
Examine GI-2 recovery
Sponsors
University of California, Irvine
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI-2 Recovery | Post-surgically until report of first bowel movement | GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of Stay | From hospital admission to discharge | Total cost of surgical stay |
| Length of Stay | From hospital admission to discharge | Total time patient is at hospital |
| Morbidity & Mortality | 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. |
| Post Reversal Bradycardia | Post surgically but prior to PACU discharge, up to 24 hours | Number of participants experiencing post-reversal bradycardia prior to discharge from PACU |
| Duration of PACU Stay | 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. |
| Time to Out of Bed | Up to 24 hours post surgery | Time for patient to be able to get out of bed and walk post surgically |
| Amount of Fluid Administration | Intraoperative and postoperative including PACU stay, up to 24 hours | Total amount of IV fluids administered during and after surgery through PACU stay. |
| Postoperative Nausea and Vomiting | Postoperative to discharge, up to 1 week | Number of Participants Experiencing PONV |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert R Field, MD
Associate Clinical Professor
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62 years |
| Body Mass Index | 26.1 kg/m^2 |
| Bowel adhesions | 58 Participants |
| Comorbidities Asthma | 8 Participants |
| Comorbidities Congestive heart failure | 2 Participants |
| Comorbidities Coronary artery bypass graft | 7 Participants |
| Comorbidities Hypertension | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Height | 167.6 cm |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 91 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 33 Participants |
| Surgery Type Ostomy closure | 2 Participants |
| Surgery Type Other | 2 Participants |
| Surgery Type Partial colectomy | 125 Participants |
| Weight | 77.5 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 7 / 66 | 13 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
None listed