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Study for the optimal compatibility dosage of naborphine combined with hydromorphone for postoperative analgesia of gynecological laparoscopy in PCIA

Study for the optimal compatibility dosage of naborphine combined with hydromorphone for postoperative analgesia of gynecological laparoscopy in PCIA

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024436
Enrollment
Unknown
Registered
2019-07-12
Start date
2019-07-15
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

gynecological laparoscopic surgery

Interventions

Group A:naborphine 0.75mg/ml + hydromorphone 25µg/ml
Group B:naborphine 0.67mg/ml + hydromorphone 33µg/ml
Group C:naborphine 0.5mg/ml + hydromorphone 50µg/ml
Group D:naborphine 0.33mg/ml + hydromorphone 67µg/ml
Group E:naborphine 0.25mg/ml + hydromorphone 75µg/ml

Sponsors

The First Affiliated Hospital of Inner Mongolia Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1 ASA grade I or II; 2 Gynecological laparoscopic surgery patients; 3 Preoperative cognitive function was normal; 4 Aged 40-65 years; 5 Body mass index 19-29 kg/m2. 6 No history of drug abuse, chronic pain and mental illness.

Exclusion criteria

Exclusion criteria: 1 History of abdominal surgery; 2 Diffuse peritonitis; 3 Severe adhesion of giant uterus or pelvic cavity; 4 Second-degree and above atrioventricular block, bradycardia (HR < 50 beats / min) and hypotension (SBP < 90mmHg); 5 Low pulmonary function; 6 Complicated with coagulation dysfunction, severe brain, liver and kidney insufficiency, endocrine system diseases and severe infectious diseases; 7 Patients with serious mental and psychological diseases can not cooperate with treatment and patients with language disorder; 8 Suspected or confirmed history of alcohol and drug abuse; 9 Allergic to naborphine hydrochloride and hydromorphone hydrochloride or their components, or patients with a history of opioid allergy; 10 Patients with limited gastric emptying or gastroparesis; 11 Patients with intestinal peristalsis or intestinal obstruction; 12 Patients who had participated in clinical trials of other drugs within nearly 4 weeks; 13 Patients with other circumstances, the researchers believe that patients who are not suitable for selection.

Design outcomes

Primary

MeasureTime frame
VAS pain score;

Secondary

MeasureTime frame
Ramsay sedation score;The total consumption of PCIA;PCA effective times;Changes of blood pressure, heart rate, respiration and oxygen saturation;Satisfaction with analgesic effect;Incidence of adverse reactions;Length of hospital stay;The recovery time of postoperative gastrointestinal function;The urinary catheter residence time after operation;

Countries

China

Contacts

Public ContactYu Jianshe

The First Affiliated Hospital of Inner Mongolia Medical University

yjsmzk@163.com+86 13847148693

Outcome results

None listed

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