Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal Surgery

NCT07271875 | Not Yet Recruiting Phase 3

• 1 other identifier: KY20252236
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a clinical research project conducted at Xijing Hospital to compare the effects of two different neuromuscular blockade reversal strategies on the recovery of gastrointestinal (GI) function after colorectal surgery. Many patients experience slow recovery of bowel function after colorectal surgery, which can lead to discomfort, nausea, vomiting, and a longer hospital stay. This study investigates whether using one medication (sugammadex) to reverse muscle relaxants used during anesthesia leads to better and faster recovery of gastrointestinal function compared to a traditional combination of medications (neostigmine with atropine). The study will include 560 adults scheduled for elective colorectal surgery. Participants will be randomly assigned to one of two groups to receive either: Sugammadex (2 mg/kg), OR Neostigmine (30 μg/kg) + Atropine (15 μg/kg) The assigned study drug will be given by intravenous injection at the end of surgery, once measurements show the muscle relaxant is starting to wear off. The patients, surgeons, outcome assessors, and statisticians will be blinded. The main goal is to see if more patients in one group recover their gastrointestinal function within 72 hours after surgery. Gastrointestinal recovery is strictly defined as both being able to tolerate food/drinks without significant nausea/vomiting AND having passed gas or had a bowel movement. The study will also compare many other important outcomes between the groups, including:

1. 1.Time to first passage of gas, first bowel movement, and first toleration of food.
2. 2.Pain scores and opioid pain medication use.
3. 3.Rates of nausea and vomiting.
4. 4.Overall quality of recovery and patient satisfaction.
5. 5.Length of hospital stay and total hospitalization costs.
6. 6.Occurrence of complications within 30 days after surgery.
7. 7.The safety of both reversal strategies will be closely monitored throughout the study by recording any adverse events.

Conditions

Postoperative Gastrointestinal Dysfunction (POGD); Postoperative Ileus; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• The proportion of patients recovering gastrointestinal function within 72 hours after surgery (assessed using the GI-3 criterion).

  GI-3 is defined as the ability to tolerate oral intake (no significant nausea or vomiting during three consecutive meals of solid food and beverages) and the passage of flatus or stool (whichever occurs first).

  up to 72 hours after surgery

Secondary Outcomes (22)

• Time to achieve GI-3 (hours)

  up to 10 days after surgery

• Time to achieve GI-2 (hours)

  up to 10 days after surgery

• Incidence of Prolonged Postoperative Ileus (PPOI)

  120 hours (5 days) after surgery

• Time to first oral intake

  Assessed up to 10 days after surgery

• Time to first passage of flatus

  Assessed up to 10 days after surgery

Study Arms (2)

Sugammadex group

EXPERIMENTAL

Sugammadex 2 mg/kg administered after surgery

Drug: Sugammadex

Neostigmine group

ACTIVE COMPARATOR

Neostigmine 30 μg/kg + Atropine 15 μg/kg administered after surgery

Drug: Neostigmine + Atropine

Interventions

Neostigmine + Atropine DRUG

Participants received Neostigmine 30 μg/kg + Atropine 15 μg/kg after surgery once a train-of-four ratio of 0.9 and sufficient spontaneous breathing were confirmed.

Neostigmine group

Sugammadex DRUG

Participants received sugammadex 2 mg/kg after surgery once a train-of-four ratio of 0.9 and sufficient spontaneous breathing were confirmed.

Sugammadex group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Preoperative Mini-Mental State Examination (MMSE) score \> 23
• Patients scheduled for elective colorectal surgery under general anesthesia. Disease diagnoses include colorectal cancer, benign polyps, benign strictures, or diverticular disease.
• Provide informed consent

You may not qualify if:

• Presence of psychiatric disorders, cognitive impairment, or language communication barriers that may affect assessment compliance.
• Body Mass Index (BMI) ≥ 35 kg/m².
• Severe hepatic dysfunction (Child-Pugh Class C) or renal dysfunction (estimated glomerular filtration rate \< 30 ml/min/1.73m² and/or receiving renal replacement therapy).
• Pre-existing severe gastrointestinal dysfunction (e.g., intestinal obstruction, active inflammatory bowel disease, severe constipation/diarrhea); receipt of neoadjuvant therapy preoperatively; planned stoma creation surgery; or scheduled for low rectal surgery (e.g., low anterior resection, abdominoperineal resection).
• History of neuromuscular disorders (e.g., myasthenia gravis) or malignant hyperthermia.
• History of opioid abuse, or chronic non-surgical pain requiring long-term analgesic therapy.
• Anticipated difficult airway, or patients planned for postoperative transfer to the intensive care unit (ICU) while intubated.
• Contraindications to the use of neostigmine, atropine, sugammadex, or rocuronium (e.g., known drug allergy, epilepsy, unstable angina, asthma, glaucoma, uncontrolled malignant arrhythmias especially atrioventricular block, severe cardiac valve stenosis); or current use of medications that may significantly influence the effects of neuromuscular blocking agents (e.g., antibiotics such as tetracyclines, aminoglycosides, polymyxins, and clindamycin; antiepileptic drugs; lithium; certain antidepressants such as sertraline and amitriptyline).
• Pregnant or lactating women.
• Current participation in other clinical trials that may interfere with the results of this study.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Interventions

Neostigmine; Atropine; Sugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statisticians are also masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor. MD &phD

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-11