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A multicenter, prospective, randomized, double-blind, controlled study on the effect of different doses of namefen on induction, maintenance and recovery of general anesthesia

A multicenter, prospective, randomized, double-blind, controlled study on the effect of different doses of namefen on induction, maintenance and recovery of general anesthesia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032183
Enrollment
Unknown
Registered
2020-04-22
Start date
2020-04-25
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

Anesthesia observation of single upper limb / clavicle fracture operation

Interventions

Placebo group:intravenous placebo (normal saline)
low-dose nalmefene group :Intravenous low-dose of nalmefene
medium-dose nalmefene group:Intravenous medium-dose of nalmefene
high-dose nalmefene group :Intravenous high-dose of nalmefene

Sponsors

Funing People's Hospital of Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 240 patients with single upper limb / clavicle fracture were selected for selective operation; 2. Patients with single and single fracture, excluding comminuted fracture, and having little difficulty in preoperative evaluation; 3. Patients with gender unlimited, ASA grade I-II, age 20-70, body mass index (BMI) 20-29kg / ?; 4. The patients who have no basic diseases of cardiopulmonary system and no history of disease attack, such as bronchospasm, asthma, etc; 5. Patients with normal intelligence, ability to understand and willing to participate in this study, and willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Patients with a long history of painful diseases; 3. Patients with allergic history of opioids or their antagonists; 4. Patients with a history of drug or alcohol dependence; 5. Patients with severe cardiopulmonary function, liver and kidney dysfunction; 6. Patients with severe snoring and obesity (BMI > 30 kg / m2); 7. Patients with history of digestive system diseases; 8. Patients with hypertension, diabetes, mental disorders and mental disorders.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale/Score;Blood concentration;bispectral index,BIS;Vital signs;OAA/S Score;Anesthesia induction observation;Anesthesia maintenance observation;Anesthesia recovery observation;

Countries

China

Contacts

Public ContactDekun Yin

Funing People's Hospital of Jiangsu Province

kundymedical@qq.com+86 15805110243

Outcome results

None listed

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