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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term-opioid-free anesthesia group. | Experimental |
| |
| Long-term-opioid anesthesia group. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil Hydrochloride | Drug | Subjects will receive remifentanil anesthesia for operative analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative numerical rating scales (NRS) at rest. | Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery. | Up to 48 hours after operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post operative nausea and vomiting (PONV). | The proportion of subjects who experienced PONV. | Up to 30 days after operation. |
| Postoperative NRS on movement. | Postoperative NRS pain score on movement, up to 48hr. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ren Liao, M.D | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Sufentanil Citrate | Drug | Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia. |
|
| Up to 48 hours after operation. |
| Postoperative complications. | Incidence of postoperative adverse reactions and complications. | Up to 30 days after operation. |
| Incidence of intraoperative adverse events. | Intraoperative . |
| Postoperative recovery of cervical spine function | Japanese Orthopaedic Association Scores.(JOA scores). | Up to 48 hours after operation. |
| Analgesic medication use before discharge。 | Up to 48 hours after operation. |
| Length of stay (LOS) in hospital | Time frame from the day of hospital admission to discharge from the hospital (unit: days). | Up to 30 days after operation. |
| Postoperative LOS | Time frame from the day of operation to discharge from the hospital (unit: days). | Up to 30 days after operation. |
| Total in-hospital cost. | Total hospitalization expenses after the destruction of costly consumables in orthopedic operation. | Up to 30 days after operation. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005283 | Fentanyl |