Skip to content

The effect of sufentanil in combination with esketamine on patient-controlled intravenous analgesia after lower limb surgery: a randomized controlled trial

The effect of sufentanil in combination with esketamine on patient-controlled intravenous analgesia after lower limb surgery: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051238
Enrollment
Unknown
Registered
2021-09-16
Start date
2021-09-08
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

lower limb surgery

Interventions

Sufentanil combined with esketamine group:Sufentanil combined with esketamine for analgesia after operation
Sufentanil group :Sufentanil for analgesia after operation

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. ASA I-III level; 2. Aged 45-80 years; 3. BMI <= 35kg/m2; 4. It is planned to undergo elective lower extremity surgery; 5. Combined spinal-epidural anesthesia is planned; 6. The patient voluntarily provides postoperative analgesia and the patient or authorizer signs the informed consent; 7. New York Heart Association (NYHA) cardiac function class I-II; 8. Patients should fast for at least 2 hours before surgery; fast for at least 6-8 hours; 9. There are no factors of difficulty in ventilation and intubation.

Exclusion criteria

Exclusion criteria: 1. Language communication barriers, no self-control operation ability; 2. Suffering from mental or neurological diseases; 3. Contraindications for spinal anesthesia, including patients who refuse spinal anesthesia, coagulation disorders (PT/APTT higher than the upper limit of the reference value), etc.; 4. Taking sedatives and analgesics, long-term use and abuse of psychotropic drugs, or drug addiction in the past 1 week; 5. Allergic to the subject drug; 6. Patients with severe risk of elevated blood pressure or intracranial pressure; 7. Patients with poorly controlled hypertension (arterial hypertension, resting systolic/diastolic blood pressure 180/100mmHg); 8. Pulmonary diseases such as airway obstruction, asthma, and known difficult airways.

Design outcomes

Primary

MeasureTime frame
The total dosage of sufentanil in PCIA 48h after operation;

Secondary

MeasureTime frame
VAS scores of subjects at 6h, 12h, 18h, 24h, 48h after operation;Total dosage of esketamine in PCIA 48h after operation;Effective compressions and total number of compressions;Seek to use other pain medications;Adverse reactions after surgery;Evaluate overall patient satisfaction;

Countries

China

Contacts

Public ContactHan Lin

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

nanlinhannansh@qq.com+86 158687108331

Outcome results

None listed

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