Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal Surgery
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorXijing Hospital
About this trial
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. Time to first passage of gas, first bowel movement, and first toleration of food. 2. Pain scores and opioid pain medication use. 3. Rates of nausea and vomiting. 4. Overall quality of recovery and patient satisfaction. 5. Length of hospital stay and total hospitalization costs. 6. Occurrence of complications within 30 days after surgery. 7. The safety of both reversal strategies will be closely monitored throughout the study by recording any adverse events.
This research aims to provide high-quality evidence to help anesthesiologists and surgeons choose the best method to reverse muscle relaxation, potentially leading to faster recovery, fewer complications, and a better overall experience for patients undergoing colorectal surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Neostigmine + Atropine
DrugParticipants 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.
Sugammadex
DrugParticipants received sugammadex 2 mg/kg after surgery once a train-of-four ratio of 0.9 and sufficient spontaneous breathing were confirmed.
Treatment groups
560 Participants
are divided into 2 treatment groupsGroup A: Sugammadex groupExperimental treatment 1 intervention
Group B: Neostigmine groupActive comparator 1 intervention
Trial outcomes
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).
Time frame
up to 72 hours after surgerySecondary outcomes
1
Time to achieve GI-3 (hours)
Defined as the time from the end of anesthesia until the patient meets the GI-3 criteria.
Time frame
up to 10 days after surgery2
Time to achieve GI-2 (hours)
GI-2 is defined as the ability to tolerate oral intake (no significant nausea or vomiting during three consecutive instances of eating and drinking) and having a bowel movement
Time frame
up to 10 days after surgery3
Incidence of Prolonged Postoperative Ileus (PPOI)
Defined as the proportion of patients who fail to meet the GI-3 criteria by 120 hours (5 days) after surgery. Diagnosis requires radiographic imaging (e.g., abdominal X-ray or CT scan) to rule out mechanical obstruction, intra-abdominal infection, or other related complications (e.g., anastomotic leakage).
Time frame
120 hours (5 days) after surgery4
Time to first oral intake
record the time from surgery to first time of oral intake
Time frame
Assessed up to 10 days after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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