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Randomized controlled trial on qNOX guidance vs Shafer's pharmacokinetics model in fentanyl-based analgesia during liver resection

Randomized controlled trial on qNOX guidance vs Shafer's pharmacokinetics model in fentanyl-based analgesia during liver resection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017011
Enrollment
Unknown
Registered
2018-07-04
Start date
2018-09-03
Completion date
Unknown
Last updated
2018-09-17

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

Conditions

Pain during liver resection

Interventions

Two groups:Use of qNOX index to guide the pain management using fentanyl during liver surgery versus Use of Shafer’s Pharmacokinetic model to guide the pain management using fentanyl during liver surg

Sponsors

Departmental resources
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective liver surgery; 2. ASA I to III; 3. Age between 18-80 years old.

Exclusion criteria

Exclusion criteria: 1. Laparoscopic surgery; 2. Concomitant non-hepatobiliary surgery; 3. Drug allergy to fentanyl/local anesthetic agents; 4. Anticipated operative duration less than 90 min; 5. Chronic pain patients; 6. Preoperative opioid consumption; 7. Patients with obstructive sleep apnea; 8. Psychiatric disorders; 9. Inability to use PCA device; 10. Severe Chronic Obstructive Airway Disease; 11. Perioperative massive bleeding with hemodynamic instability; 12. History of severe postoperative nausea and vomiting.

Design outcomes

Primary

MeasureTime frame
Total dose of fentanyl administered intraoepratively;

Secondary

MeasureTime frame
Time to first analgesic demand at RR;Total dose of rescue fentanyl given at RR;Sedation score at RR;VAS for analgesia at rest and during cough, sedation, nausea and pruritus at RR and during the first 24 hours postoperatively;Total PCA fentanyl consumption within the first 24 hours postoperatively;No of patients requiring naloxone for opioid overdose;Total doses of naloxone given for opioid overdose;No of patients requiring antiemetic for PONV;Chronic pain assessment at 3-month postoperative interval;

Countries

China

Contacts

Public ContactDr Wong Tak-Kin

Tuen Mun Hospital

wtk635@ha.org.hk+852 96214286

Outcome results

None listed

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