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A single center, randomized, double-blind, parallel controlled trial for the effect of nalmefene on the quality of resuscitation in patients undergoing general anesthesia

A single center, randomized, double-blind, parallel controlled trial for the effect of nalmefene on the quality of resuscitation in patients undergoing general anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035846
Enrollment
Unknown
Registered
2020-08-18
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Effect of nalmefene on recovery quality of patients undergoing general anesthesia

Interventions

Experimental group:0.25ug/kg Nalmefene
Control group:1ml normal saline will be injected intravenously

Sponsors

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old; 2. Elective general anesthesia for orthopedics, urology and thoracic surgery; 3. ASA class I or II; 4. BMI 18 to 30kg/ m2; 5. Anesthesia time was 2-4 hours, and anesthetic analgesics (sufentanil and remifentanil) were used during operation 6. The patient used electronic intravenous analgesia pump after operation; 7. Signed Informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous severe cerebrovascular accident and other nervous system diseases; 2. Mental illness, long-term use of drugs that affect the function of the central nervous system, benzodiazepines or opioids; 3. History of allergy to narcotic drugs; 4. History of drug addiction and alcoholism; 5. The patient was diagnosed with severe cardiopulmonary disease, or active heart disease, or abnormal liver function (AST and ALT were 1.5 times higher than the normal value), and renal insufficiency (serum creatinine and urea nitrogen were 1.2 times higher than the normal value); 6. Participate in other clinical trials within 4 weeks; 7. Abnormal cognition or communication determined by the researcher; 8. Emergency and critical condition occurred during the operation.

Design outcomes

Primary

MeasureTime frame
The time from the end of operation to Aldrete score >=9;

Countries

China

Contacts

Public ContactLiu Jueying

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

fuliuzh@aliyun.com+86 13917751664

Outcome results

None listed

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