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Clinical Observation on the Use of Low-dose Opioid Receptor Antagonist Combined with Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Spinal Surgery Patients

Clinical Observation on the Use of Low-dose Opioid Receptor Antagonist Combined with Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Spinal Surgery Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113043
Enrollment
Unknown
Registered
2025-11-24
Start date
2021-07-28
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Opioid-related adverse reactions

Interventions

Sufentanil + Nalmefene group:Intravenous patient-controlled analgesia (PCA) postoperatively includes sufentanil at a dose of 1.5–2.5 µg/kg plus naloxone at a continuous infusion rate of 0.06 µg/kg/h,
Sufentanil + Butorphanol group:Intravenous patient-controlled analgesia (PCA) postoperatively includes sufentanil at a dose of 1.5–2.5 µg/kg plus butorphanol at a dose of 30–40 µg/kg, with all other p
Sufentanil group:Intravenous patient-controlled analgesia (PCA) postoperatively includes sufentanil at a dose of 1.5–2.5 µg/kg, diluted with normal saline to a total volume of 100 mL, with a backgroun

Sponsors

Wenzhou Medical University Affiliated Second Hospital, Wenzhou Medical University Affiliated Yuying Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in this experiment and sign the informed consent form. 2. American Society of Anesthesiologists (ASA) physical condition classification I-III level. 3. Patients aged 18 years or older undergoing spinal surgery.

Exclusion criteria

Exclusion criteria: 1. Patients still on tracheal intubation after surgery; 2. Patients with difficulty in verbal communication; 3. Patients with severe liver or kidney diseases; 4. Patients taking psychotropic drugs; 5. Patients with a history of allergic reaction to the studied drug.

Design outcomes

Primary

MeasureTime frame
Incidence of opioid-related adverse reactions, such as postoperative nausea and vomiting, and abdominal distension.;Time to first ambulation;

Secondary

MeasureTime frame
Visual Analog Scale (VAS) scores for pain at rest and during movement at various time points within 48 hours postoperatively.;Time to first water intake;Time to first liquid diet;Time to start passive in-bed exercise;Length of postoperative hospital stay;Patient satisfaction;Time to first anal exhaust;Total intraoperative and PACU analgesic consumption, and rescue analgesic use in the ward.;Time to resumption of normal diet postoperatively.;

Countries

China

Contacts

Public ContactLi Jun

Wenzhou Medical University Affiliated Second Hospital, Wenzhou Medical University Affiliated Yuying Children's Hospital

LIjun_0312@163.com+86 188 9534 6557

Outcome results

None listed

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