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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex group | Experimental | Sugammadex 2 mg/kg administered after surgery |
|
| Neostigmine group | Active Comparator | Neostigmine 30 μg/kg + Atropine 15 μg/kg administered after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve GI-3 (hours) | Defined as the time from the end of anesthesia until the patient meets the GI-3 criteria. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D001285 | Atropine |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Statisticians are also masked
| 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. |
|
| 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). | 120 hours (5 days) after surgery |
| Time to first oral intake | record the time from surgery to first time of oral intake | Assessed up to 10 days after surgery |
| Time to first passage of flatus | record the time from surgery to first time passage of flatus | Assessed up to 10 days after surgery |
| Time to first defecation | record the time from surgery to first time defecation | Assessed up to 10 days after surgery |
| Time to first ambulation | record the time from surgery to first time ambulation | 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 | 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. | 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 | At 24, 48, and 72 hours after surgery |
| Total opioid consumption | the postoperative opioid comsumption will recorded in morphine equivalent dose. | 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) | At 24, 48, and 72 hours after surgery |
| Postoperative Quality of Recovery | Assessed using the QoR-15 questionnaire preoperatively and daily | From postoperative day 1 to day 7 (or until discharge, whichever comes first) |
| Incidence of postoperative delirium | Assessed using the Confusion Assessment Method (CAM) | 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. | 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. | 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. | Preoperatively, postoperative day 7, and postoperative day 30 |
| Postoperative length of hospital stay | the time from surgery to hospital discharge | From postoperative Day 1 to hospital discharge, assessed up to postoperative 30 days |
| Total hospitalization costs | in Chinese Yuan, RMB | 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 | 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 | 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. | From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery) |
| D009861 |
| Onium Compounds |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |