Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection
- Conditions
- Intestinal Disease
- Interventions
- Registration Number
- NCT06112353
- Lead Sponsor
- University of California, Irvine
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
- Age 18 or older
- Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neostigmine plus Glycopyrrolate Neostigmine Injectable Solution 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 Sugammadex Sugammadex injection 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)
- Primary Outcome Measures
Name Time Method GI-2 Recovery Up to 24 hours post surgery GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
- Secondary Outcome Measures
Name Time Method Presence of Bowel Adhesion Intraoperative Scar tissue found in bowels
Number of Participants Experiencing PONV Postoperative to discharge, up to 1 week Post operative nausea and vomiting
Cost of Stay From hospital admission to discharge, up to 30 days Total cost of surgical stay
Length of Stay From hospital admission to discharge, up to 60 days Total time patient is at hospital
Morbidity & Mortality Rate 30 days post surgery Symptomatic disease presence and death
Duration of PACU Stay From surgical end time to PACU discharge, up to 24 hours Time in PACU, not owing to bed availability
Number of Participants Experiencing Post Reversal Bradycardia Post surgically but prior to PACU discharge, up to 24 hours Slowed heart rate following reversal
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 IV fluid administration during surgery
Trial Locations
- Locations (1)
UC Irvine Medical Center
🇺🇸Orange, California, United States