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Clinical study of nalbuphine combined with sufentanil PCIA for postoperative analgesia in patients undergoing abdominal surgery

Clinical study of nalbuphine combined with sufentanil PCIA for postoperative analgesia in patients undergoing abdominal surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033977
Enrollment
Unknown
Registered
2020-06-19
Start date
2020-06-04
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

Issues related to analgesia after abdominal surgery

Interventions

experimental group:Nalbuphine 0.5mg/ml + sufentanil 0.5µg/ml + tropisetron 5mg
control group:Sufentanil 1µg/ml + tropisetron 5mg

Sponsors

Qingdao Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with abdominal surgery (single abdominal incision >= 5 cm); 2. ASA I~II level; 3. Aged 18-65 years, regardless of gender; 4. Body Mass Index (BMI): 29kg/m2 >= BMI >= 18.5kg/m2;

Exclusion criteria

Exclusion criteria: 1. Poor compliance and unable to cooperate with the operation; 2. Women who are pregnant or breastfeeding; 3. Acute heart failure; unstable angina; myocardial infarction within 6 months before screening; resting ECG heart rate = 160 mmHg or SBP = 1.5 * ULN, blood creatinine is greater than the upper limit of normal value; 6. Patients with severe respiratory tract lesions (obstructive sleep apnea syndrome, acute respiratory infections, acute onset of chronic obstructive pulmonary disease, uncontrolled asthma, etc.); 7. The electrolyte is not within the following normal range: Na+ (130150 mmol/L), K+ (3.55.5 mmol/L), Ca2+ (2.02.9mmol/L); 8. Abnormal blood coagulation function (PT or APTT exceeds 1.5 times the upper limit of normal value); 9. History of neurological diseases; history of chronic pain; drug addiction and alcoholism; long-term application of opioids; 10. People who are allergic to nalbuphine hydrochloride or its components, patients with a history of allergy to opioids;11. Patients with restricted gastric emptying and gastroparesis; 12. Patients with weakened intestinal peristalsis and intestinal obstruction; 13. Those who have participated in clinical trials of other drugs in the last 4 weeks; 14. With other circumstances, the investigator believes that it is not suitable for the selected patients.

Design outcomes

Primary

MeasureTime frame
VAS pain score (rest and activity) (each observation time);

Secondary

MeasureTime frame
Total number of PCA and effective number of PCA;Ramsay sedation score;Evaluation of patients' satisfaction with the analgesic effect after 48h;Incidence of adverse reactions such as respiratory depression, nausea and vomiting, drowsiness, and itchy skin;Postoperative catheter removal time, gastrointestinal function recovery time (exhaust time), time to start activity and length of hospitalization;

Countries

China

Contacts

Public ContactMingshan Wang

Department of Anesthesiology, Qingdao Municipal Hospital

wmsqingdao@163.com+86 18661675608

Outcome results

None listed

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