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Investigating and Comparing the Effects of Hydromorphone and Buprenorphine Tartrate, Two Opioid Analgesics, on the Gut Microbiota of ICU Patients Without Mechanical Ventilation

Investigating and Comparing the Effects of Hydromorphone and Buprenorphine Tartrate, Two Opioid Analgesics, on the Gut Microbiota of ICU Patients Without Mechanical Ventilation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109551
Enrollment
Unknown
Registered
2025-09-22
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU patients with non-mechanical ventilation

Interventions

Butorphanol tartrate group:None
Hydromorphone group:None

Sponsors

The People's Hospital of Baiyun District Guangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years; 2.Non-mechanically ventilated patients (including those who have been weaned from mechanical ventilation) with an expected ICU stay of >72 hours; 3.Patients with moderate to severe pain (NRS = 4 or BPS = 5, CPOT = 3) treated with hydromorphone or buprenorphine tartrate for analgesia, aiming to achieve comfort and safety, and to facilitate the implementation of life support measures; 4.Obtain the informed consent of patients or family members.

Exclusion criteria

Exclusion criteria: 1.Pregnant or breastfeeding; 2.Confirmed acute severe intracranial or spinal neurological diseases caused by vascular, infectious, intracranial expansion, or injury; 3.Presence of non-compensated acute circulatory failure (severe hypotension with MAP<55 mmHg despite adequate fluid resuscitation and vasopressor therapy); 4.Severe bradycardia (heart rate <55 beats per minute) or suffering from second- or third-degree atrioventricular block (except for those with a pacemaker installed); 5.Inability to obtain pain scores or any condition that may severely interfere with the collection of study data; 6.A history of long-term use of opioids or opioid addiction; 7.A known history of allergy to any of the study drugs; 8.Suffering from severe or acute asthma, or accompanied by severe carbon dioxide retention, head injury, or intracranial damage leading to respiratory depression; 9.Intestinal obstruction in the danger period (patients with existing or progressive risk of gastrointestinal obstruction, especially those with paralytic ileus); 10.Having participated in this study before or concurrently participating in any other interventional study (any study that assigns patients to different treatment groups).

Design outcomes

Primary

MeasureTime frame
Intestinal flora structure and diversity;

Secondary

MeasureTime frame
Fecal Calprotectin;Serum IL-6/IL-10;

Countries

China

Contacts

Public ContactWang Shengnan

The People 's Hospital of Baiyun District Guangzhou; Southern Medical University Southern Hospital

wsnpumc@smu.edu.cn+86 20 6623 0609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026