Long-term-opioid-free Anesthesia
Conditions
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.
Interventions
Subjects will receive remifentanil anesthesia for operative analgesia.
Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing anterior cervical surgery., sign the informed consent form * Age above 18 years old * ASA Ⅰ-Ⅲ.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Incidence of intraoperative adverse events. | Intraoperative . | — |
| Postoperative recovery of cervical spine function | Up to 48 hours after operation. | Japanese Orthopaedic Association Scores.(JOA scores). |
| Incidence of post operative nausea and vomiting (PONV). | Up to 30 days after operation. | The proportion of subjects who experienced PONV. |
| 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). |
| Postoperative LOS | Up to 30 days after operation. | Time frame from the day of operation 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. |
| Analgesic medication use before discharge。 | Up to 48 hours after operation. | — |
Countries
China
Outcome results
None listed