Clinical Investigation of Postoperative analgesia with sufentanil-mRCT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12001983

Enrollment

Unknown

Registered

2012-03-04

Start date

2012-04-04

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

postoperative pain

Interventions

control group:Postoperative analgesia with fentanil (first dose2ug/kg, PCIA0.2ug/(kg·ml))

1:Postoperative analgesia with sufentanil (first dose 0.2ug/kg, PCIA0.0175ug/(kg·ml))

2:Postoperative analgesia with sufentanil (first dose 0.2ug/kg, PCIA0.02ug/(kg·ml))

3:Postoperative analgesia with sufentanil (first dose 0.2ug/kg, PCIA0.0225ug/kg·ml)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Participate other clinical drug test during nearly 3 months; 2. ASA>=3; 3. BMI 18 to 30; 4. Allergic to sufentanil; 5. Emergency without preoperative preparation; 6. With serious cardiovascular disease; 7. Serious dehydration electrolyte disorder or shock; 8. Hepatic and renal function seriously abnormal; (1) to be aged 18 to 65, either sex; (2) ASA1-2, who had a good performance status; (3) Elective surgery, general anesthesia; (4) No infectious fever or bacteremia; (5) Sign the ICF, voluntary to paticipate and could coordinate.

Exclusion criteria

Exclusion criteria: 1. Participate other clinical drug test during nearly 3 months; 2. ASA>=3; 3. 18>=BMI or 30<=BMI; 4. Allergic to sufentanil; 5. Emergency without preoperative preparation; 6. With serious cardiovascular disease; 7. Serious dehydration electrolyte disorder or shock; 8. Hepatic and renal function seriously abnormal; 9. Neurological and muscular dystrophies;malignant hyperthermia; 10. Hypertension without good control; 11. With serious cardiovascular disease or pulmonary disease; 12. Pregnancy or lactation women; 13. With serious neuropathy or psychotic disorders; 14. With serious alcoholism or drug abuser.

Design outcomes

Primary

Measure	Time frame
PCA observation indexes (reality pressing numbers/effective pressing numbers and dose);VAS score;Ramsay sedation score;	—

Secondary

Measure	Time frame
nausea score;vomiting score;itching score;	—

Countries

China

Contacts

Public ContactQingping Wu

wu_qingping1968@yahoo.com.cn+86 13971605283

Outcome results

None listed

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