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Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention
Phase 2 trial testing Methylnaltrexone in Postoperative Ileus in 82 participants. Completed in 12 May 2021.
| Lead sponsor | Ohio State University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 82 |
| Start date | 21 February 2019 |
| Primary completion | 4 April 2021 |
| Estimated completion | 12 May 2021 |
| Sites | 1 location across United States |
Ohio State University
18 and older, any sex, with Postoperative Ileus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The time it takes for the participant to have a bowel movement from the end of surgery.
| Group | Value | 95% CI |
|---|---|---|
| Study Arm: Methylnaltrexone | 61.8 | 35.7 – 93.6 |
| Placebo Arm | 50.7 | 17.8 – 110.8 |
The number of hours it takes for the participant to meet all discharge criteria and be released from the hospital.(Time-to-discharge/discharge eligibility)
| Group | Value | 95% CI |
|---|---|---|
| Study Arm: Methylnaltrexone | 105.0 | 84.6 – 110.2 |
| Placebo Arm | 90.7 | 85.4 – 111.3 |
The time it takes for the participant to discharge
| Group | Value | 95% CI |
|---|---|---|
| Study Arm: Methylnaltrexone | 4.29 | 3.38 – 8.39 |
| Placebo Arm | 4.19 | 3.23 – 7.69 |
The amount of daily narcotics (in morphine milli-equivalents) given to a patient (average of post op day 1 - 3)
| Group | Value | 95% CI |
|---|---|---|
| Study Arm: Methylnaltrexone | 136.8 | 107.9 – 168.6 |
| Placebo Arm | 148.5 | 94.8 – 203.7 |
Time frame: Immediately pre-operative to 30 Days post-operative. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Study Arm: Methylnaltrexone | Placebo Arm |
|---|---|---|---|
| Migratory artheralgias/ gout flare up | Immune system disorders | — | — |
| Disorientation/ Hallucinations secondary to alcohol withdrawal | Psychiatric disorders | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Wound Dehiscence | Infections and infestations | — | — |
| Stroke | Vascular disorders | — | — |
| Non-ST-elevation myocardial infarction (NSTEMI) | Cardiac disorders | — | — |
| Altered mental status (AMS) | Psychiatric disorders | — | — |
| hypoxemia, loss of response | Blood and lymphatic system disorders | — | — |
| Syncope; dehydration; Fracture- Right foot | Social circumstances | — | — |
| Post-Operative Ileus | Gastrointestinal disorders | — | — |
| urinary tract infection (UTI) and hyponatremia | Renal and urinary disorders | — | — |
| Atrial fibrillation (also called AFib or AF) with rapid ventricular rate or response (RVR).; | Cardiac disorders | — | — |
| Reaction | System | Study Arm: Methylnaltrexone | Placebo Arm |
|---|---|---|---|
| > 3 bowel movements in 1 day | Gastrointestinal disorders | — | — |
| Wound dehiscence / drainage from incision | Infections and infestations | — | — |
| AMS and emesis during attempted bowel movement. | Psychiatric disorders | — | — |
| Hemoglobin drop | Blood and lymphatic system disorders | — | — |
| Intraoperatively, a Cerebrospinal Fluid (CSF) leak was noted. | Surgical and medical procedures | — | — |
| Diagnosis of Acute Kidney Injury | Renal and urinary disorders | — | — |
| Post-operative illeus | Gastrointestinal disorders | — | — |
| increasing pain with concern for infection without drainage or dis | Musculoskeletal and connective tissue disorders | — | — |
| Hypotension, syncope | Cardiac disorders | — | — |
| Kidney Disease Improving Global Outcomes Stage III (kidney disease) | Renal and urinary disorders | — | — |
| left airspace disease concerning for brewing aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Migratory artheralgias/ gout flare up, Disorientation/ Hallucinations secondary to alcohol withdrawal, Abdominal Pain, Wound Dehiscence, Stroke, Non-ST-elevation myocardial infarction (NSTEMI), Altered mental status (AMS), hypoxemia, loss of response.
Data from ClinicalTrials.gov NCT03852524 adverse events section.
This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal surgery without increasing narcotic usage or otherwise disrupting the recovery course of patients. Using a double-blind randomized design, either subcutaneous MNTX (0.15 mg/kg rounded to 8 mg or 12 mg) or placebo will be administered starting before surgery and then daily for three days. Information will be collected from medical records in IHIS up to 30 days prior to surgery and then for up to 30 days after surgery.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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