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Clinical observation of different doses of nalmefene combined with hydromorphone on postoperative analgesia following colorectal cancer surgery

Clinical observation of different doses of nalmefene combined with hydromorphone on postoperative analgesia following colorectal cancer surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033520
Enrollment
Unknown
Registered
2020-06-03
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Colorectal cancer

Interventions

Low dose Group:hydromorphone 0.1mg/kg +nalmefene 3µg/kg +normal saline to 100ml
Ultra Low Dose Group:hydromorphone 0.1mg/kg +nalmefene 1µg/kg +normal saline to 100ml
Control Group:hydromorphone 0.1mg/kg +normal saline to 100ml

Sponsors

Peking University Shougang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years; 2. 18 < BMI < 30; 3. ASA I - III patients; 4. Patients who underwent selective radical operation for colorectal cancer; 5. Patients who had signed the informed consent before the operation and voluntarily joined the study.

Exclusion criteria

Exclusion criteria: 1. Patients with preoperative nausea, vomiting and skin history; 2. Patients with serious liver and kidney dysfunction and other important organ diseases; 3. Patients with history of neuropsychiatric diseases; 4. Patients with a history of alcohol or opioid abuse; 5. Patients with allergic history of related drugs; 6. Patients who can't read or recognize VAS score and Ramsay grade correctly; 7. The patients who had used opioids, antiemetics and antipruritics in 24 hours before operation, and antidepressants or monoamine oxidase inhibitors in 15 days before operation; 8. Those who need to enter ICU for further treatment after operation.

Design outcomes

Primary

MeasureTime frame
Postoperative pain intensity;

Secondary

MeasureTime frame
Bolus frequency;analgesic rescue;Level of sedation;nausea;vomiting;antiemetic rescue;pruritus;Respiratory depression;Time to gastrointestinal recovery;Time to out-of-bed activity;Time to drainage tube removal;The duration of hospital stay;The degree of satisfaction with their pain management experience;

Countries

China

Contacts

Public ContactZhenggang Guo

Peking University Shougang Hospital

shouganggzg@163.com+86 13581918132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026