UC Irvine Medical Center
Orange, California, 92868, United States
NCT Number: NCT06112353
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
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Orange, California, 92868, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Examine GI-2 recovery
Other names: Neostigmine plus Glycopyrrolate, Group B
Examine GI-2 recovery
Other names: Sugammadex, Group A
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
Time frame: From hospital admission to discharge
Total cost of surgical stay
Time frame: From hospital admission to discharge
Total time patient is at hospital
Time frame: 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.
Time frame: Post surgically but prior to PACU discharge, up to 24 hours
Number of participants experiencing post-reversal bradycardia prior to discharge from PACU
Time frame: 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 frame: Up to 24 hours post surgery
Time for patient to be able to get out of bed and walk post surgically
Time frame: Intraoperative and postoperative including PACU stay, up to 24 hours
Total amount of IV fluids administered during and after surgery through PACU stay.
Time frame: Postoperative to discharge, up to 1 week
Number of Participants Experiencing PONV
Looking for future studies?
Notify MeUniversity of California, Irvine
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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