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Efficacy and safety of oxycodone preemptive analgesia in patients undergoing gynecological laparoscopic surgery based on blood drug concentration monitoring: a randomized, double-blind, placebo-controlled clinical trial

Efficacy and safety of oxycodone preemptive analgesia in patients undergoing gynecological laparoscopic surgery based on blood drug concentration monitoring: a randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068884
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Gynecologic laparoscopic surgery

Interventions

Oxycodone group:Intravenous injection of oxycodone 0.1mg/kg 10 min before skin incision
Normal saline group:10 minutes before skin incision, inject physiological saline with the same volume of 0.1mg/kg oxycodone intravenously

Sponsors

Anesthesia Department of the Sixth Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 18-60; ASA grade I - II; BMI 18.5~29.9kg/m2 Sign the informed consent form to confirm that you can participate in the study voluntarily according to relevant rules

Exclusion criteria

Exclusion criteria: It is known that there is a history of allergy to drugs used during operation; There are serious liver and kidney dysfunction; History of long-term use of analgesics; Take monoamine oxidase inhibitor at the same time or within 2 weeks after discontinuation; Mental illness is unable to cooperate with instructions; The operation duration is more than 2 hours

Design outcomes

Primary

MeasureTime frame
Hemodynamic indexes;VAS score;Blood concentration;

Secondary

MeasureTime frame
Postoperative adverse events;

Countries

China

Contacts

Public ContactWanchao Yang

The Sixth Affiliated Hospital of Harbin Medical University

dachao_1980@126.com+86 137 9663 6010

Outcome results

None listed

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