Skip to content

The Effect of Nalbuphine on the Quality of Early Recovery in Elderly Patients After Laparoscopic Colon Cancer Surgery: A Randomized Controlled Trial.

The Effect of Nalbuphine on the Quality of Early Recovery in Elderly Patients After Laparoscopic Colon Cancer Surgery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114176
Enrollment
Unknown
Registered
2025-12-08
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

colorectal cancer

Interventions

Nalbuphine group:Intravenous injection of Nalbuphine, Nalbuphine patient-controlled analgesia pump for postoperative analgesia.
Normal Saline Group:Intravenous injection of Normal Saline

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years; 2. BMI 18-28 kg/m^2; 3. Preoperative diagnosis of colon cancer, planned for laparoscopic radical surgery for colon cancer; 4. ASA grade I-III, able to tolerate surgery; 5. Patient or their legal representative has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Preexisting chronic pain or long-term use of analgesics before surgery; 2. Allergy to nalfurafine or any components of the investigational drug; 3. Severe cardiopulmonary dysfunction before surgery (including severe aortic stenosis, NYHA class III-IV heart failure; left ventricular ejection fraction less than 50%, severe pneumonia, pulmonary edema, acute exacerbation of COPD, etc.), liver and kidney dysfunction, or other comorbidities; 4. Severe cognitive impairment or psychiatric disorders preventing completion of scale assessments; 5. Patients who refuse to participate or have poor compliance.

Design outcomes

Primary

MeasureTime frame
Postoperative 24h, 48h, 72h QoR-15 scores;

Secondary

MeasureTime frame
Occurrence of respiratory depression;Occurrence of postoperative delirium;other adverse events;Nausea and Vomiting Score;Anesthesia-related information (type of anesthesia, medications used for anesthesia, sedation, and analgesia); Surgery-related information (duration of surgery, intraoperative blood loss, intraoperative urine output);Pain scores: Resting and activity VAS scores at 2h, 24h, 48h, and 72h postoperatively;Sedation scores: Ramsay Sedation Scale scores at 2h, 24h, 48h, and 72h postoperatively.;Itching Severity Scale;

Countries

China

Contacts

Public ContactSun Wei

the First Affiliated Hospital of Shan Tou University Medical College

md.sunwei@gmail.com+86 135 8057 9456

Outcome results

None listed

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