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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
128
Examine GI-2 recovery
Examine GI-2 recovery
UC Irvine Medical Center
Orange, California, United States
RECRUITINGGI-2 Recovery
GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
Time frame: Up to 24 hours post surgery
Cost of Stay
Total cost of surgical stay
Time frame: From hospital admission to discharge, up to 30 days
Length of Stay
Total time patient is at hospital
Time frame: From hospital admission to discharge, up to 60 days
Morbidity & Mortality Rate
Symptomatic disease presence and death
Time frame: 30 days post surgery
Number of Participants Experiencing Post Reversal Bradycardia
Slowed heart rate following reversal
Time frame: Post surgically but prior to PACU discharge, up to 24 hours
Duration of PACU Stay
Time in PACU, not owing to bed availability
Time frame: 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
Time frame: Up to 24 hours post surgery
Amount of Fluid Administration
IV fluid administration during surgery
Time frame: Intraoperative
Presence of Bowel Adhesion
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Scar tissue found in bowels
Time frame: Intraoperative
Number of Participants Experiencing PONV
Post operative nausea and vomiting
Time frame: Postoperative to discharge, up to 1 week