Long-term-opioid-free Anesthesia in Anterior Cervical Surgery
- Conditions
- Long-term-opioid-free Anesthesia
- Interventions
- Registration Number
- NCT05548465
- Lead Sponsor
- West China Hospital
- Brief Summary
We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patients undergoing anterior cervical surgery., sign the "informed consent form"
- Age above 18 years old
- ASA Ⅰ-Ⅲ.
- Pregnant or lactating women.
- Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc
- Allergic to the materials or drugs used in this study.
- Patients with current/previous gastrointestinal bleeding and gastric ulcers;
- Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness.
- Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Long-term-opioid anesthesia group. Sufentanil Citrate - Long-term-opioid-free anesthesia group. Remifentanil Hydrochloride -
- Primary Outcome Measures
Name Time Method Postoperative numerical rating scales (NRS) at rest. Up to 48 hours after operation. Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery.
- Secondary Outcome Measures
Name Time Method Postoperative NRS on movement. Up to 48 hours after operation. Postoperative NRS pain score on movement, up to 48hr.
Postoperative complications. Up to 30 days after operation. Incidence of postoperative adverse reactions and complications.
Postoperative recovery of cervical spine function Up to 48 hours after operation. Japanese Orthopaedic Association Scores.(JOA scores).
Length of stay (LOS) in hospital Up to 30 days after operation. Time frame from the day of hospital admission to discharge from the hospital (unit: days).
Total in-hospital cost. Up to 30 days after operation. Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.
Incidence of intraoperative adverse events. Intraoperative . Postoperative LOS Up to 30 days after operation. Time frame from the day of operation to discharge from the hospital (unit: days).
Analgesic medication use before discharge。 Up to 48 hours after operation. Incidence of post operative nausea and vomiting (PONV). Up to 30 days after operation. The proportion of subjects who experienced PONV.
Trial Locations
- Locations (1)
Department of Anesthesiology, West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China