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A Comparative Study on the Efficacy of Dexmedetomidine versus Nalbuphine in Preventing Postoperative Shivering in Renal Transplant Recipients: A Single-Center, Prospective, Randomized Trial Protocol

A Comparative Study on the Efficacy of Dexmedetomidine versus Nalbuphine in Preventing Postoperative Shivering in Renal Transplant Recipients: A Single-Center, Prospective, Randomized Trial Protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120709
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-03-18
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Postoperative Shivering

Interventions

Dexmedetomidine group:Dexmedetomidine (0.5 µg/kg, diluted to a total volume of 20 mL) was administered via intravenous infusion pump over 10 minutes, starting 30 minutes before the anticipated end of
Nalbuphine group:Nalbuphine (0.07 mg/kg, diluted in a total volume of 20 mL) was administered by intravenous infusion pump over a 10-minute period, commencing 30 minutes prior to the anticipated end o
Normal saline (0.9%) group:20 mL of 0.9% normal saline was administered via intravenous infusion pump over a 10-minute period, commencing 30 minutes prior to the anticipated end of surgery

Sponsors

The First Affiliated Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age: 18 years <= y < 65 years; 3. Patients undergoing kidney transplantation for chronic renal failure; 4. Body mass index (BMI): 18–30 kg/m^2 (including boundary values), male patients not less than 50 kg, female patients not less than 45 kg; 5. ASA classification: Class III–IV

Exclusion criteria

Exclusion criteria: 1.Severe decompensated cardiovascular, respiratory, or hepatic function (Child-Pugh class B/C); 2. Initial body temperature >38.0°C or <36.0°C; 3. Long-term use of analgesics, sedatives, and antidepressants; 4. History of allergy or other serious adverse reactions to anesthetic drugs; 5. Language comprehension barriers or mental disorders; 6. Severe hypothyroidism or hyperthyroidism, metabolic diseases, and neuromuscular disorders; 7. Patients transferred to the Intensive Care Unit (ICU) postoperatively; 8. Having undergone general anesthesia within 30 days prior to surgery or scheduled for general anesthesia again within 30 days; 9. Planned prolonged airway protection or mechanical ventilation support postoperatively; 10. Use of drugs that may affect body temperature or shivering response within 24 hours preoperatively; 11. Severe bradycardia (heart rate <50 beats per minute).

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative shivering (Wrench scale grade >= 1) in the PACU;

Secondary

MeasureTime frame
Postoperative recovery quality;Incidence of severe chills (wrench grade >= 3);Numerical Rating Scale Score;Ramsay Sedation Scale Score;Incidence of adverse reactions (hypotension, bradycardia, drowsiness, nausea, and vomiting);

Countries

China

Contacts

Public ContactLing Dong

The First Affiliated Hospital of Shandong First Medical University

1668@sdhospital.com.cn+86 151 6915 5151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026