Postoperative Gastrointestinal Dysfunction (POGD)Phase 3NCT07271875
Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal Surgery
A Phase 3 study testing Neostigmine + Atropine and Sugammadex in people with Postoperative Gastrointestinal Dysfunction (POGD) and Postoperative Ileus, run by Xijing Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Gastrointestinal Dysfunction (POGD), Postoperative Ileus, Colorectal Surgery
- What is being tested?
- Neostigmine + Atropine and Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: Effect of Neuromuscular Reversal With Neostigmine/Atropine Versus Sugammadex on Postoperative Gastrointestinal Function Recovery Following Colorectal Surgery
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).
Read more
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:
- Time to first passage of gas, first bowel movement, and first toleration of food.
- Pain scores and opioid pain medication use.
- Rates of nausea and vomiting.
- Overall quality of recovery and patient satisfaction.
- Length of hospital stay and total hospitalization costs.
- Occurrence of complications within 30 days after surgery.
- 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.
- Conditions
- Postoperative Gastrointestinal Dysfunction (POGD), Postoperative Ileus, Colorectal Surgery
- Being tested
- Neostigmine + Atropine, Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine + AtropineDrug
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.
SugammadexDrug
Participants received sugammadex 2 mg/kg after surgery once a train-of-four ratio of 0.9 and sufficient spontaneous breathing were confirmed.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex group | Experimental | Sugammadex 2 mg/kg administered after surgery Receives: Drug: Sugammadex |
| Neostigmine group | Active comparator | Neostigmine 30 μg/kg + Atropine 15 μg/kg administered after surgery Receives: Drug: Neostigmine + Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 72 hours after surgery
Secondary outcomes (22)
Time to achieve GI-3 (hours)
Defined as the time from the end of anesthesia until the patient meets the GI-3 criteria.
Measured: up to 10 days after surgery
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
Measured: up to 10 days after surgery
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).
Measured: 120 hours (5 days) after surgery
Time to first oral intake
record the time from surgery to first time of oral intake
Measured: Assessed up to 10 days after surgery
Time to first passage of flatus
record the time from surgery to first time passage of flatus
Measured: Assessed up to 10 days after surgery
Time to first defecation
record the time from surgery to first time defecation
Measured: Assessed up to 10 days after surgery
Time to first ambulation
record the time from surgery to first time ambulation
Measured: Assessed up to 10 days after surgery
Incidence of adverse events during the recovery period
any adverse events such as hypoxia will be recorded within this 2hrs time frame
Measured: Within 2 hours after extubation
Intake, Feeling nausea, Emesis, physical Exam, and Duration of symptoms (I-FEED) score at 24, 48, and 72 hours after surgery
The I-FEED scoring system incorporates five elements: intake (score: 0, 1, 3), feeling nauseated (score: 0, 1, 3), emesis (score: 0, 1, 3), results of physical exam (score: 0, 1, 3), and duration of symptoms (score: 0, 1, 2), with a total score ranging from 0 to 14. A higher score indicates poorer postoperative gastrointestinal recovery.
Measured: At 24, 48, and 72 hours after surgery
Visual Analog Scale (VAS) score at rest and during activity
The VAS score ranges from 0 to 10, with a higher score indicating greater pain intensity
Measured: At 24, 48, and 72 hours after surgery
Total opioid consumption
the postoperative opioid comsumption will recorded in morphine equivalent dose.
Measured: Within 24, 48, and 72 hours after surgery
Postoperative Nausea and Vomiting (PONV)
PONV scores (range from 0-3, a higher score indicates that the patient is experiencing more severe and frequent symptoms of postoperative nausea and vomiting), number of vomiting episodes, and the use of rescue antiemetic medications (name and dose)
Measured: At 24, 48, and 72 hours after surgery
Postoperative Quality of Recovery
Assessed using the QoR-15 questionnaire preoperatively and daily
Measured: From postoperative day 1 to day 7 (or until discharge, whichever comes first)
Incidence of postoperative delirium
Assessed using the Confusion Assessment Method (CAM)
Measured: Within 7 days after surgery (or until discharge, whichever comes first)
Time to meet medically defined discharge criteria (days)
Defined as the time when the patient meets all of the following criteria: ability to independently consume fluids/nutrition, adequate pain control with oral analgesics, ability to ambulate independently, recovery of gastrointestinal function according to GI-3 criteria, and absence of medical contraindications.
Measured: Assessed up to 30 days after surgery
Patient-assessed time to readiness for discharge (days)
Defined as the time when the patient meets the medically defined discharge criteria and subjectively agrees to be discharged.
Measured: Assessed up to 30 days after surgery
Quality of life assessment using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire
The EQ-5D-5L consists of 25 items (rated from 1 = best condition to 5 = worst condition) across five domains: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, with a cumulative score ranging from 5 to 25. Higher EQ-5D-5L scores indicate poorer health status, reflecting greater difficulty in daily activities, higher levels of pain, or emotional distress. Conversely, lower scores indicate better health with fewer or no problems.
Measured: Preoperatively, postoperative day 7, and postoperative day 30
Postoperative length of hospital stay
the time from surgery to hospital discharge
Measured: From postoperative Day 1 to hospital discharge, assessed up to postoperative 30 days
Total hospitalization costs
in Chinese Yuan, RMB
Measured: From hospital admission to hospital discharge, assessed up to postoperative 30 days
Incidence of complications
All complications occurring within 30 days after surgery will be recorded and graded according to the Clavien-Dindo classification system
Measured: Within 30 days after surgery
Days Alive and Out of Hospital within 30 days after surgery (DAOH30)
DAOH30 is defined as the number of days the patient is alive and not hospitalized in any medical facility (including rehabilitation institutions) within 30 days after surgery
Measured: Within 30 days after surgery
Adverse events (AEs)
Recorded any adverse event during the study peroid, no matter the AEs related to the intervention or not.
Measured: From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Gastrointestinal Dysfunction (POGD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271875
- Sponsor's protocol ID
- KY20252236
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Reversal With Neostigmine/Atropine Versus Sugammadex on Postoperative Gastrointestinal Function Recovery Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07271875
- Acronym / sponsor ID
- KY20252236
- Conditions
- Postoperative Gastrointestinal Dysfunction (POGD), Postoperative Ileus, Colorectal Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Time to first passage of gas, first bowel movement, and first toleration of food.
- Pain scores and opioid pain medication use.
- Rates of nausea and vomiting.
- Overall quality of recovery and patient satisfaction.
- Length of hospital stay and total hospitalization costs.
- Occurrence of complications within 30 days after surgery.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex group | Experimental | Drug: SugammadexSugammadex 2 mg/kg administered after surgery |
| Neostigmine group | Active comparator | Drug: Neostigmine + AtropineNeostigmine 30 μg/kg + Atropine 15 μg/kg administered after surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine + AtropineParticipants 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. | Drug | Neostigmine group |
| SugammadexParticipants received sugammadex 2 mg/kg after surgery once a train-of-four ratio of 0.9 and sufficient spontaneous breathing were confirmed. | Drug | Sugammadex group |
Primary outcome
The proportion of patients recovering gastrointestinal function within 72 hours after surgery (assessed using the GI-3 criterion).
Time frame: up to 72 hours after surgery
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).
22 secondary outcomes
Time to achieve GI-3 (hours)
Time frame: up to 10 days after surgery
Time to achieve GI-2 (hours)
Time frame: up to 10 days after surgery
Incidence of Prolonged Postoperative Ileus (PPOI)
Time frame: 120 hours (5 days) after surgery
Time to first oral intake
Time frame: Assessed up to 10 days after surgery
Time to first passage of flatus
Time frame: Assessed up to 10 days after surgery
Time to first defecation
Time frame: Assessed up to 10 days after surgery
Time to first ambulation
Time frame: Assessed up to 10 days after surgery
Incidence of adverse events during the recovery period
Time frame: Within 2 hours after extubation
Intake, Feeling nausea, Emesis, physical Exam, and Duration of symptoms (I-FEED) score at 24, 48, and 72 hours after surgery
Time frame: At 24, 48, and 72 hours after surgery
Visual Analog Scale (VAS) score at rest and during activity
Time frame: At 24, 48, and 72 hours after surgery
Total opioid consumption
Time frame: Within 24, 48, and 72 hours after surgery
Postoperative Nausea and Vomiting (PONV)
Time frame: At 24, 48, and 72 hours after surgery
Postoperative Quality of Recovery
Time frame: From postoperative day 1 to day 7 (or until discharge, whichever comes first)
Incidence of postoperative delirium
Time frame: Within 7 days after surgery (or until discharge, whichever comes first)
Time to meet medically defined discharge criteria (days)
Time frame: Assessed up to 30 days after surgery
Patient-assessed time to readiness for discharge (days)
Time frame: Assessed up to 30 days after surgery
Quality of life assessment using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Time frame: Preoperatively, postoperative day 7, and postoperative day 30
Postoperative length of hospital stay
Time frame: From postoperative Day 1 to hospital discharge, assessed up to postoperative 30 days
Total hospitalization costs
Time frame: From hospital admission to hospital discharge, assessed up to postoperative 30 days
Incidence of complications
Time frame: Within 30 days after surgery
Days Alive and Out of Hospital within 30 days after surgery (DAOH30)
Time frame: Within 30 days after surgery
Adverse events (AEs)
Time frame: From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neostigmine + Atropine and Sugammadex in people with Postoperative Gastrointestinal Dysfunction (POGD) and Postoperative Ileus, run by Xijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients recovering gastrointestinal function within 72 hours after surgery (assessed using the GI-3 criterion). (time frame: up to 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.