Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

University of California Irvine (UCI)

Status and phase: Enrolling; Phase 4

Conditions: Intestinal Disease

Treatments: Drug: Neostigmine Injectable Solution; Drug: Sugammadex injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06112353

2295

Field 100931 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

Neostigmine plus Glycopyrrolate

Active Comparator group

Description:

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

Treatment:

Drug: Neostigmine Injectable Solution

Sugammadex

Active Comparator group

Description:

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)

Treatment:

Drug: Sugammadex injection