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Low dose nalmefene combined with opioids for postoperative analgesia in laparoscopic gastrointestinal surgery

Low dose nalmefene combined with opioids for postoperative analgesia in laparoscopic gastrointestinal surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047746
Enrollment
Unknown
Registered
2021-06-26
Start date
2020-07-01
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

postoperative analgesia

Interventions

Experimental Group:nalmefene 0.2 µg/kg
Control Group:normal saline 0.2 µg/kg

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients receiving laparoscopic gastrointestinal surgery ; 2. American Society of Anesthesiologists physical status is I-III; 3. Aged 18 to 75 years.

Exclusion criteria

Exclusion criteria: 1. Subject is allergic to nalmefenesubject has pregnancy; 2. Subject has a diagnosis of severe cardiac, neurological and vascular diseases; 3. Subject has a diagnosis of severe high blood pressure(preoperative systolic BP >= 180mmHg or preoperative diastolic BP >= 110mmHg ); 4. Subject with severe impairment of hepatic and renal function, gastrointestinal bleeding ulcer, ischemic peripheral vascular disease, aspirin asthma or hematologic disorder ; 5. Subject has severe opioids dependence ; 6. Subject can not complete the subjective assessment scale due to mental disorders and other reasons; 7. Subject with BMI >=30kg/m2; 8. Subject with BMI<18kg/m2; 9. Subject refuses to participate in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of major side effects of opioid analgesia;opioid consumption;

Secondary

MeasureTime frame
pain;influence of pain on sleep mood;abdominal distention;Oxygen saturation;Respiratory rate;postoperative analgesia pump drug consumption;rescue analgesics;Time of first ambulation after operation;first feeding;time of detubation of stomach tube;Discharge time;

Countries

China

Contacts

Public ContactMi Weidong

Chinese PLA General Hospital

wwdd1962@aliyun.com+86 10 66938252

Outcome results

None listed

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