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Safety and effectiveness of nalbuphine for postoperative analgesia in ERAS pathway of pancreaticoduodenectomy

Safety and efficacy of nalbuphine for postoperative analgesia in ERAS pathway of pancreaticoduodenectomy: a randomized, controlled, double-blinded tria

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026640
Enrollment
Unknown
Registered
2019-10-16
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

pancreaticoduodenectomy

Interventions

Group S:PCIA: sufentanil 0.05 mg/kg/h and ondansetron 12 mg diluted with saline to 150 ml
Group SN:PCIA: fufentanil 0.025 mg/kg/h, nalbuphine 0.025mg/kg/h and ondansetron 12 mg diluted with saline to 150 ml
Group N:PCIA: nalbuphine 0.05mg/kg/h and ondansetron 12 mg diluted with saline to 150 ml

Sponsors

Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with middle and lower common bile duct cancer, periampullary cancer, duodenal malignancy and early pancreatic head cancer were definitely diagnosed; 2. Aged >=18 years patients undergoing selective pancreaticoduodenectomy; 3. ASA I-III.

Exclusion criteria

Exclusion criteria: 1. BMI >18.5kg/m2; 2. Those with a history of serious heart, brain, lung, liver and kidney diseases; 3. Preoperative blood pressure is more than 180/110 mmHg in patients with hypertension; 4. Those with neuromuscular system diseases and psychiatric disorders; 5. Those are suspected of abusing of narcotic analgesics or sedatives; 6. Those have a history of allergy to emulsion and opioids; 7. Those who are unwilling to cooperate or unable to communicate.

Design outcomes

Primary

MeasureTime frame
heart rate;Noninvasive blood pressure;Respiratory frequency;Pulse oxygen saturation;Rasmay sedation score;Postoperative analgesia-related adverse reactions;VAS; effective pressing times of PCIA;the ratio of effective pressing times of PCIA and total pressing times;Time of pulling out catheter;Time of leaving the bed activity;Exhaust time;

Secondary

MeasureTime frame
Changes of liver and kidney function before and after operation;the degree of comfort score;Satisfaction score;Postoperative hospital duration;Total cost after operation;

Countries

China

Contacts

Public ContactXie Jianqin

Lanzhou University Second Hospital

952456735@qq.com+86 13919127974

Outcome results

None listed

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